MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/PLATE: SYNFIX EVOLUTION; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Vertebral Fracture (4520); Intervertebral Disc Compression or Protrusion (4524)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra): clinical outcomes in patients undergoing anterior lumbar interbody fusion with synfix evolution, for a total of 337 patients (165 male and 171 female) who received treatment for anterior lumbar interbody fusion (alif) approach or combined with posterior instrumentation with synfix evolution from 1 september 2015 to 1 march 2020.The average patient age was 55.45 ± 13.57 years.The average body mass index (bmi) was 28.51 ± 5.62.In a majority of patients, 82.8%, synfix evolution implant was used in a standalone application.Fifty-one patients were also treated with pedicle screws/rods (15.1%), and 279 without posterior supplemental fixation (82.8%).Among these, 1 patient had vivigen, while others were from unknown manufacturer or competitors.Following complications were reported: revision / reoperation (see table 8) - (n=23) required reoperation procedures: 2 at intraop, 2 prior to discharge, 10 at 6 weeks, 6 at 3 months, and 3 at 6 months - (n=12) had a revision in which supplemental posterior fixation was added or removed.The synfix evolution device was not removed in any of these patients.6 of these at 6 weeks, 4 at 3 months, and 2 at 6 months surgical/intraoperative and prior to discharge complications (see table 6; n=25) - (n=16) had intraoperative complications: (n=4) dural tear while (n=3) dural tear, posterior surgery, and (n=9) vessel injury - (n=19) had prior to discharge complications: (n=5) anemia, (n=4) csf leak, (n=2) dural tear, (n=1) epidural hematoma, (n=1) hematoma, (n=1) hypotension, (n=1) ileus, (n=2) infection, and (n=7) other postoperative complications (see table 7; n=133) - (n=6) cage subsidence: 5 occurred at 6 weeks and 1 at 3 months.- (n=5) dvt: 2 occurred at 6 weeks and 3 at 3 months.- (n=2) foot drop which occurred at 6 months - (n=6) hardware failure: 2 occurred at 6 weeks, 1 at 3 months, 2 at 6 months, and 1 at 12 months - (n=8) infection: 7 occurred at 6 weeks and 1 at 3 months - (n=1) loss of bladder control which occurred at 6 weeks - (n=1) nerve damage which occurred at 6 weeks - (n=2) numbness / paraesthesia, lower extremity which occurred at 6 weeks - (n=46) pain (si, low back, leg): 16 occurred at 6 weeks, 11 occurred at 3 months, 3 occurred at 6 months, and 16 occurred at 12 months - (n=1) pain, myofascial which occurred at 3 months - (n=5) pain, other: 2 occurred at 6 weeks, 1 at 3 months, and 2 at 6 months - (n=66) radiculopathy: 17 occurred at 6 weeks, 13 at 3 months, 25 at 6 months, and 11 at 12 months - (n=1) radiographic screw halo which occurred at 6 months - (n=1) sacroiliitis which occurred at 6 months - (n=1) sciatica which occurred at 6 months - (n=4) si dysfunction: 1 occurred at 6 weeks, 1 at 3 months, and 2 at 6months - (n=5) spondylolisthesis: 2 occurred at 6 weeks, 1 at 6 months, and 2 at 12 months - (n=1) spondylosis which occurred at 6 months - (n=10) vertebral fracture: 8 occurred at 6 weeks, 1 at 6 months, and 1 at 12 months - (n=1) weakness, lower extremity which occurred at 3 months - (n=6) wound related (dehiscence, seroma, delayed healing): 3 occurred at 6 weeks and 3 occurred at 3 months - (n=2) vascular claudication which occurred at 3 months - (n=14) other: 3 occurred at 6 weeks, 6 at 3 months, and 5 occurred at 6 months device related (n=2) - (n=1) recurring spondylolisthesis ¿ breakage of internal orthopedic device at 6 weeks - (n=1) hardware failure at 3 months this report is for an unk - cage/plate: synfix evolution.This is report 1 of 5 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown cage/plate: synfix evolution/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - CAGE/PLATE: SYNFIX EVOLUTION
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16183633
• MDR Text Key: 307499911
• Report Number: 8030965-2023-00543
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other