MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: OPAL; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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

Patient Problems Nerve Damage (1979); Pain (1994); Non-union Bone Fracture (2369)

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 (ddra) ¿ evaluation of healthcare outcomes of patients treated with depuy synthes conduit plif, conduit curved tlif, and opal implants during fusion procedures in the lumbar spine¿ for patients who underwent posterior or transforaminal posterior interbody fusion procedures of the lumbar spine between (b)(6) 2017, and (b)(6) 2022 (conduit plif and curved tlif) or between (b)(6) 2007, and (b)(6) 2022 (opal).Of the included patients 5,118 patients (2,236 males and 2,882 females with a mean age of 59 years) were implanted with opal spacers, 804 patients (337 males and 467 females with a mean age of 63 years) were implanted with conduit plif and 345 patients (152 males and 193 females with a mean age of 62 years).The complications as per icd 9 & 10 categorization identified in premier healthcare database were reported as follows: opal spacer system 51 patients had reoperation within 0-3 months after index procedure (38 for infection, 6 for seroma, 7 for hematoma, and 4 for dural tear).60 patients had revision within 0-3 months after index procedure.32 patients had revision 4-6 months after index procedure.80 patients had revision 7-12 months after index procedure.116 patients had revision 13-24 months after index procedure.Among the total of 288 patients who had revision, 20 had back pain, 66 had radiculopathy, 4 had myelopathy, 99 had device-related complications, and 32 had pseudarthrosis.Conduit plif cage and conduit tlif cage overall 15 patients had reoperation within 0-3 months after index procedure (12 for infection, 1 for seroma, and 2 for dural tear).19 patients had revision within 0-3 months after index procedure.5 patients had revision 4-6 months after index procedure.9 patients had revision 7-12 months after index procedure.11 patients had revision 13-24 months after index procedure.Among the total of 44 patients who had revision, 3 had back pain, 25 had radiculopathy, 16 had device-related complications, and 9 had pseudarthrosis.This report involves one unk - cage/spacers: opal.This report is related to (b)(4).This is report 4 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.D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown cage/spacers: opal /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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/SPACERS: OPAL
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 17200998
• MDR Text Key: 317993921
• Report Number: 8030965-2023-08044
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,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: 06/26/2023
• 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: 06/06/2023
• 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