Trial Outcomes & Findings for MESA Rail™ AIS Study - Preservation of Curve Correction (NCT NCT02062606)

NCT ID: NCT02062606

Last Updated: 2021-04-12

Results Overview

Restoration and maintenance of thoracic kyphosis and coronal curve correction. Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.

• Recruitment status: TERMINATED
• Target enrollment: 188 participants
• Primary outcome timeframe: Baseline (up to 90 days before surgery), 24 months
• Results posted on: 2021-04-12

Participant Flow

Participant milestones

Measure	K2M MESA Rail™ Deformity System Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail Deformity System that had: 1. Diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles were noted but not restrictive). 2. An age at time of surgery of ≥ 11 years old and ≤ 21 years old
Overall Study STARTED	188
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	89

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The study Case Report Forms did not include Race/Ethnicity

Baseline characteristics by cohort

Measure	Demographics and Baseline Characteristics n=188 Participants This is a demographic and baseline characteristics of the patient population. This includes parameters such as Age, Gender, Height, Weight Body Mass Index (BMI) and Tobacco Usage.
Age, Categorical <=18 years	180 Participants n=188 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=188 Participants
Age, Categorical >=65 years	0 Participants n=188 Participants
Age, Continuous	14.65 years STANDARD_DEVIATION 2.16 • n=188 Participants
Sex: Female, Male Female	139 Participants n=188 Participants
Sex: Female, Male Male	49 Participants n=188 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) Asian	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) Black or African American	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) White	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) More than one race	0 Participants The study Case Report Forms did not include Race/Ethnicity
Race (NIH/OMB) Unknown or Not Reported	0 Participants The study Case Report Forms did not include Race/Ethnicity
Region of Enrollment United States	170 participants n=188 Participants
Region of Enrollment New Zealand	4 participants n=188 Participants
Region of Enrollment Australia	14 participants n=188 Participants
Height	160.4 cm STANDARD_DEVIATION 10.8 • n=188 Participants
Weight	55.3 kg STANDARD_DEVIATION 13.53 • n=188 Participants
Body Mass Index (BMI)	21.43 kg/m^2 STANDARD_DEVIATION 4.66 • n=188 Participants
Tobacco Use Never	186 Participants n=188 Participants
Tobacco Use Quit	1 Participants n=188 Participants
Tobacco Use Currently Use	1 Participants n=188 Participants

PRIMARY outcome

Timeframe: Baseline (up to 90 days before surgery), 24 months

Population: 98 of the 99 participants who returned at 24 Months had the thoracic kyphosis measurement.

Restoration and maintenance of thoracic kyphosis and coronal curve correction.

Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.

Outcome measures

Measure	Right Leg/Hip pain scores on the VAS	24 Month n=98 Participants Baseline in quality of life scores on the SRS-22r	24 Month Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months	—	-3.84 degrees Interval -5.91 to -1.76	—	—	—	—

PRIMARY outcome

Timeframe: Up to 24 months

Population: This is an analysis of the number of participants that reported any form of adverse event. Overall participants with any AE or SAE. 5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.

Number of participants with SAE and AE for the various intervals

Outcome measures

Measure	Right Leg/Hip n=147 Participants pain scores on the VAS	24 Month n=188 Participants Baseline in quality of life scores on the SRS-22r	24 Month n=160 Participants Patient satisfaction at 12 Month	6 to 12 Months n=135 Participants participants with SAE and AE	12 to 24+ Months n=99 Participants participants with SAE and AE	Overall n=188 Participants Overall number of participants with SAE and AEs
Number of Participants With Adverse Events Any SAE : Procedure Related	0 participants	8 participants	0 participants	1 participants	2 participants	11 participants
Number of Participants With Adverse Events Any SAE : Device Related	0 participants	2 participants	0 participants	1 participants	2 participants	5 participants
Number of Participants With Adverse Events Any AE	21 participants	62 participants	7 participants	25 participants	36 participants	98 participants
Number of Participants With Adverse Events Any AE : Procedure Related	12 participants	44 participants	0 participants	9 participants	18 participants	67 participants
Number of Participants With Adverse Events Any AE : Device Related	3 participants	16 participants	0 participants	6 participants	7 participants	26 participants
Number of Participants With Adverse Events Any AE : Mild	17 participants	44 participants	6 participants	20 participants	29 participants	79 participants
Number of Participants With Adverse Events Any AE : Moderate	4 participants	19 participants	1 participants	5 participants	10 participants	31 participants
Number of Participants With Adverse Events Any AE : Severe	0 participants	5 participants	1 participants	1 participants	0 participants	7 participants
Number of Participants With Adverse Events Any SAE	0 participants	10 participants	1 participants	4 participants	3 participants	17 participants
Number of Participants With Adverse Events Any SAE : Mild	0 participants	3 participants	0 participants	1 participants	1 participants	5 participants
Number of Participants With Adverse Events Any SAE : Moderate	0 participants	4 participants	0 participants	2 participants	2 participants	7 participants
Number of Participants With Adverse Events Any SAE : Severe	0 participants	4 participants	1 participants	1 participants	0 participants	6 participants

SECONDARY outcome

Timeframe: Baseline (up to 90 days before surgery), 24 months

Population: 13 out of the 99 participants who returned at 24 months, did not complete the survey.

Evaluation of the improvement of the Back VAS and Hip/Leg VAS (assessed together) at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness /tingling and the location of symptoms were captured and evaluated.

VAS scale ranged from 0 - 100mm with the 100mm accounting for the highest level of pain.

Outcome measures

Measure	Right Leg/Hip n=86 Participants pain scores on the VAS	24 Month n=86 Participants Baseline in quality of life scores on the SRS-22r	24 Month n=86 Participants Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months	-2 score on a scale Standard Deviation 17.8	-16.9 score on a scale Standard Deviation 29.5	-0.2 score on a scale Standard Deviation 13.2	—	—	—

SECONDARY outcome

Timeframe: Baseline (up to 90 days before surgery), 24 months

Population: While 99 participants completed 24 month interval, 14 patients out of the 99 did not did not complete the survey.

The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS 22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self- image/appearance (SA), mental health (MH) and satisfaction with treatment (ST).

The scores vary from 1 to 5 in which 5 is the best health quality of life of patients.

Outcome measures

Measure	Right Leg/Hip pain scores on the VAS	24 Month n=85 Participants Baseline in quality of life scores on the SRS-22r	24 Month Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months	—	0.6 score on a scale Standard Deviation 0.7	—	—	—	—

SECONDARY outcome

Timeframe: 12 months and 24 months

Population: Patient self-assessment of the procedure at 12M and 24M

At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).

Outcome measures

Measure	Right Leg/Hip pain scores on the VAS	24 Month n=135 Participants Baseline in quality of life scores on the SRS-22r	24 Month n=99 Participants Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Patient Satisfaction Satisfied · Yes	—	124 Participants	86 Participants	—	—	—
Patient Satisfaction Satisfied · No	—	4 Participants	2 Participants	—	—	—
Patient Satisfaction Satisfied · Not Reported	—	7 Participants	11 Participants	—	—	—
Patient Satisfaction Repeat Procedure · Yes	—	105 Participants	76 Participants	—	—	—
Patient Satisfaction Repeat Procedure · No	—	23 Participants	12 Participants	—	—	—
Patient Satisfaction Repeat Procedure · Not Reported	—	7 Participants	11 Participants	—	—	—

SECONDARY outcome

Timeframe: 24 months

Population: Patients who were rated based on the outcome of their treatment and would indicate either Excellent, Good or Fair/Satisfactory. No responses are shown under missing

At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows:

Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment.

Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference.

Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited.

Poor: symptoms or signs unchanged or worsened.

Outcome measures

Measure	Right Leg/Hip pain scores on the VAS	24 Month n=99 Participants Baseline in quality of life scores on the SRS-22r	24 Month Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria Fair/Satisfactory	—	2 Participants	—	—	—	—
Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria Good	—	15 Participants	—	—	—	—
Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria Excellent	—	78 Participants	—	—	—	—
Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria Missing	—	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During surgery

Population: 186 patients had their surgery times recorded. There were 3 additional procedures staged increasing the overall number of units analyzed to 189.

The length of the surgical procedure from the initial incision to final closure were captured.

Outcome measures

Measure	Right Leg/Hip pain scores on the VAS	24 Month n=189 surgeries Baseline in quality of life scores on the SRS-22r	24 Month Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Length of Surgery Time	—	267.01 Minutes Standard Deviation 79.89	—	—	—	—

SECONDARY outcome

Timeframe: During surgery

Population: 183 subjects had anesthesia time included. There were 3 staged procedures increasing the overall number of units analyzed to 186.

The length of time the patient is under anesthesia was captured.

Outcome measures

Measure	Right Leg/Hip pain scores on the VAS	24 Month n=186 surgeries Baseline in quality of life scores on the SRS-22r	24 Month Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Length of Anesthesia Time	—	373.67 Minutes Standard Deviation 91.97	—	—	—	—

SECONDARY outcome

Timeframe: During surgery

Population: 187 patients had blood loss included. There were 3 additional procedures staged increasing the overall number of units analyzed to 190.

The amount of blood loss over the entire length of the surgery was captured.

Outcome measures

Measure	Right Leg/Hip pain scores on the VAS	24 Month n=190 surgeries Baseline in quality of life scores on the SRS-22r	24 Month Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Estimated Blood Loss	—	672.34 Cubic Centimeters Standard Deviation 588.14	—	—	—	—

SECONDARY outcome

Timeframe: Admission to Discharge

Population: 186 patients completed admit and discharge dates

The length of the hospital stay from the date of admission to the date of discharge.

Outcome measures

Measure	Right Leg/Hip pain scores on the VAS	24 Month n=186 surgeries Baseline in quality of life scores on the SRS-22r	24 Month Patient satisfaction at 12 Month	6 to 12 Months participants with SAE and AE	12 to 24+ Months participants with SAE and AE	Overall Overall number of participants with SAE and AEs
Length of Hospital Stay	—	5.28 Days Standard Deviation 1.79	—	—	—	—

SECONDARY outcome

Timeframe: Pre-Op to 24 months

Population: Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.

The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the change in percentage of participants who were able to return to work without any restrictions

Outcome measures

Measure	Right Leg/Hip n=160 Participants pain scores on the VAS	24 Month n=188 Participants Baseline in quality of life scores on the SRS-22r	24 Month n=181 Participants Patient satisfaction at 12 Month	6 to 12 Months n=147 Participants participants with SAE and AE	12 to 24+ Months n=135 Participants participants with SAE and AE	Overall n=99 Participants Overall number of participants with SAE and AEs
Change in Percentage of Participants Able to Return to Work/School Missing	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Change in Percentage of Participants Able to Return to Work/School Unemployed, unrelated to back/leg conditions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Percentage of Participants Able to Return to Work/School Not attending work/school by choice	7 Participants	11 Participants	22 Participants	2 Participants	3 Participants	0 Participants
Change in Percentage of Participants Able to Return to Work/School Unable to go due to back/leg pain/conditions	4 Participants	0 Participants	57 Participants	0 Participants	0 Participants	0 Participants
Change in Percentage of Participants Able to Return to Work/School Attending work/school with some restrictions	104 Participants	5 Participants	83 Participants	44 Participants	14 Participants	4 Participants
Change in Percentage of Participants Able to Return to Work/School Attending work/school with no restrictions	44 Participants	172 Participants	19 Participants	101 Participants	117 Participants	93 Participants

SECONDARY outcome

Timeframe: Pre-Op to 24 months

Population: Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.

The types and dosages of any narcotics taken by the patient pre- and post-surgery was documented.

Outcome measures

Measure	Right Leg/Hip n=160 Participants pain scores on the VAS	24 Month n=188 Participants Baseline in quality of life scores on the SRS-22r	24 Month n=181 Participants Patient satisfaction at 12 Month	6 to 12 Months n=147 Participants participants with SAE and AE	12 to 24+ Months n=135 Participants participants with SAE and AE	Overall n=99 Participants Overall number of participants with SAE and AEs
Use of Narcotics Post-surgery Back Meds · None	118 Participants	128 Participants	46 Participants	114 Participants	112 Participants	78 Participants
Use of Narcotics Post-surgery Back Meds · Non-narcotics or NSAIDS	29 Participants	53 Participants	28 Participants	28 Participants	22 Participants	16 Participants
Use of Narcotics Post-surgery Back Meds · Intermittent short-acting narcotics	9 Participants	6 Participants	77 Participants	5 Participants	1 Participants	1 Participants
Use of Narcotics Post-surgery Back Meds · Chronic daily short-acting narcotics	2 Participants	1 Participants	18 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Back Meds · Chronic daily long-acting narcotics	1 Participants	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Back Meds · IV or injected narcotics	0 Participants	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Back Meds · Epidural/Facet injection	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Back Meds · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants
Use of Narcotics Post-surgery Non-Back Meds · None	141 Participants	157 Participants	151 Participants	125 Participants	118 Participants	84 Participants
Use of Narcotics Post-surgery Non-Back Meds · Non-narcotics or NSAIDS	18 Participants	31 Participants	22 Participants	22 Participants	17 Participants	13 Participants
Use of Narcotics Post-surgery Non-Back Meds · Intermittent short-acting narcotics	0 Participants	0 Participants	7 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · Chronic daily short-acting narcotics	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · Chronic daily long-acting narcotics	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · IV or injected narcotics	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · Epidural/Facet injection	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Use of Narcotics Post-surgery Non-Back Meds · Missing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

Adverse Events

Participants With Adverse Events

Serious events: 17 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants With Adverse Events n=188 participants at risk Overall participants with any AE or SAE. 5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
Blood and lymphatic system disorders Infectious mononucleosis	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal Pain	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal pain upper	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Nausea	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Vomiting	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Complications associated with device	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Cyst	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Discomfort	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Hepatobiliary disorders Cholecystitis	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Infection	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Pneumonia	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Wound infection	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Wound dehiscence	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Headache	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Motor dysfunction	1.6% 3/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Sensory loss	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Product Issues Device failure	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Anxiety	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Depression	0.53% 1/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Medical device removal	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.

Other adverse events

Measure	Participants With Adverse Events n=188 participants at risk Overall participants with any AE or SAE. 5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
Blood and lymphatic system disorders Anaemia	3.2% 6/188 • Number of events 6 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Blood and lymphatic system disorders Infectious mononucleosis	0.53% 1/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Blood and lymphatic system disorders Splenomegaly	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Cardiac disorders Cardiac disorder	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Cardiac disorders Tachycardia	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Eye disorders Conjunctivitis	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal discomfort	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal pain	1.6% 3/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Abdominal pain upper	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Constipation	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Diarrhoea	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Functional gastrointestinal disorder	1.6% 3/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Nausea	2.1% 4/188 • Number of events 4 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Salivary gland mucocoele	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Gastrointestinal disorders Vomiting	2.1% 4/188 • Number of events 4 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Chest pain	5.3% 10/188 • Number of events 11 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Chills	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Complication associated with device	2.1% 4/188 • Number of events 5 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Cyst	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Flank pain	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Hypertrophy	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Pain	8.5% 16/188 • Number of events 20 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Pyrexia	2.1% 4/188 • Number of events 4 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Respiratory complication associated with device	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
General disorders Swelling	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Immune system disorders Drug hypersensitivity	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Abscess	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Infection	2.1% 4/188 • Number of events 4 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Influenza	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Otitis externa	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Otitis media	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Pharyngitis streptococcal	0.53% 1/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Viral pharyngitis	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Infections and infestations Wound infection	1.6% 3/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Fall	3.7% 7/188 • Number of events 12 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Incision site discharge	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Joint injury	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Limb injury	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Post procedural complication	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Road traffic accident	2.1% 4/188 • Number of events 4 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Suture related complication	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Wound	1.1% 2/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Injury, poisoning and procedural complications Wound dehiscence	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Investigations Blood calcium decreased	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Investigations Body temperature decreased	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Investigations Weight decreased	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Metabolism and nutrition disorders Dehydration	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 8/188 • Number of events 15 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Back pain	12.8% 24/188 • Number of events 30 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Muscle spasm	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Muscular weakness	0.53% 1/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Musculoskeletal apin	8.0% 15/188 • Number of events 18 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Myalgia	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Neck pain	2.7% 5/188 • Number of events 5 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 3/188 • Number of events 5 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Pelvic deformity	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Spinal disorder	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Carpal tunnel syndrome	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Dizziness	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Dysaesthesia	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Headache	1.6% 3/188 • Number of events 4 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Hypoaesthesia	4.3% 8/188 • Number of events 9 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Musculoskeletal and connective tissue disorders Migraine	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Motor dysfunction	1.6% 3/188 • Number of events 4 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Neuralgia	1.1% 2/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Paraesthesia	1.1% 2/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Poor quality sleep	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Spinal muscular atrophy	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Syncope	1.6% 3/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Nervous system disorders Vertigo	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Product Issues Device failure	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Anxiety	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Renal and urinary disorders Bladder dysfunction	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Musculoskeletal chest pain	2.7% 5/188 • Number of events 5 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Body tinea	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Dermatitis contact	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Erythema	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Folliculitis	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Kerion	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Pruritus	1.6% 3/188 • Number of events 3 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Rash	2.1% 4/188 • Number of events 4 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Skin and subcutaneous tissue disorders Skin irritation	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Surgical and medical procedures Incisional drainage	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Haematoma	1.1% 2/188 • Number of events 2 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Hypotension	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Vascular disorders Orthostatic hypotension	0.53% 1/188 • Number of events 1 • From Operative to 24+ Months Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.

Additional Information

Marissa Conrad, Senior Director of Clinical and Medical Affairs

Stryker Spine

Phone: 201-749-8162

Email: marissa.conrad@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Institution/PI shall not disclose/use any confidential/proprietary information (CI) disclosed to/developed by the Institution during the study. Institution/PI agree to hold the results of the Study in confidence, and shall not disclose them except with prior written consent of K2M. Institution agrees to submit any Articles to K2M for review prior to publication and agrees to edit out any confidential information identified by K2M.
• Publication restrictions are in place

Restriction type: OTHER