MAUDE Adverse Event Report: SYNTHES GMBH UNK - FACET WEDGES; ORTHOSIS, PEDICLE SPINAL FIXATION

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Nerve Damage (1979); Non-union Bone Fracture (2369); Osteolysis (2377); Neck Pain (2433); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 260 patients (268 procedures) who underwent posterior instrumentation (c0-th1) procedures between (b)(6) 2005 to (b)(6) 2021.There were 147 males and 121 females with a mean age of 62.8 years.It was not specified in the spine tango registry report which of the devices mentioned have caused the adverse events.It was also not specified in which country the adverse events have occurred.Thus, each country mentioned in the surgery activity will be captured conservatively and complications will be reported as follows: 7 patients had intraoperative general complications: anaesthesiological (n=1), other complications (n=2).24 patients had postoperative general complications: cardiovascular (n=1), pulmonary (n=7), cerebral (n=2), kidney / urinary (n=3), liver / gi (n=1), death (n=2), other compications (n=5).7 patients had intraoperative surgical complications: dural lesion (n=3), vascular injury (n=2), other complications (n=1).31 patients had postoperative surgical complications: epidural hematoma (n=2), other hematoma (n=2), radiculopathy (n=1), csf leak / pseudomeningocele (n=2), motor dysfunction (n=6), sensory dysfunction (n=3), bowel / bladder dysfunction (n=2), wound infection superficial (n=4), wound infection deep (n=2), implant malposition (n=1), other complications (n=4).63 patients had a fair (n=52) and poor (n=11) outcome.35 patients had postoperative complications: sensory dysfunction (n=6), motor dysfunction (n=4), non-union (n=4), implant failure (n=4), instability (n=2), wound infection superficial (n=1), extravertebral hematoma (n=2), implant malposition (n=1), recurrence of symptoms (n=2), graft complication (n=2), internal medicine (n=2), adjacent segment pathology (n=1), central nervous system (n=1), other (n=3).25 patients had reoperations at any level due to: adjacent segment pathology (n=1), hardware removal (n=3), implant failure (n=3), instability (n=1), neurocompression (n=2), other reasons (n=4).3 patients had reoperations at same level due to: hardware removal (n=2), neurocompression (n=1), other reasons (n=1).This is for unknown depuy synthes spine facet wedge.This is report 3 of 12 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 facet wedges/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Reporter is a j&j employee.Complainant part is not expected to be returned for manufacturer review/investigation.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 - FACET WEDGES
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• 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: 14316442
• MDR Text Key: 294678252
• Report Number: 8030965-2022-03002
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• 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: 05/07/2022
• 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: 04/07/2022
• 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): Required Intervention