MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: OPAL; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown opal interbody cage/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j 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.

Event Description

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 230 patients (mean age of 49 years) who were operated with the combination of expedium posterior instrumentation and opal interbody cage between (b)(6) 2006 and (b)(6) 2020.The following complications have been identified as per the swedish spine registry (swespine) report: general complications - intraoperative complications: 6 patients had dural tear.1 patient had misplaced implant.General complications ¿ postoperative complications within 1st follow-up year: 2 patients had deep surgical site infection.4 patients had superficial surgical site infection.General complications ¿ reintervention during stay: 1 patient drain of deep infection.1 patient had repair of dural injury.1 patient had replacement of implant.Readmission: 1 patient had adjustment of implant.5 patients had drain of deep infection.1 patient had drain of hematoma.3 patients had refusion.5 patients had removal of implant.1 patient had repair of dural injury.1 patient had readmisison to stop bleeding.This is for the unknown synthes opal interbody cage.This report captures the reported event of dural tear.This is report 1 of 3 for product complaint (b)(4).

Event Description

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 357 patients (mean age of 48 years, 53 percent are females) who were operated with the combination of expedium posterior instrumentation and opal interbody cage between (b)(6) 2006 and (b)(6) 2022.The following complications have been identified as per the swedish spine registry (swespine) report: general complications - intraoperative complications: 6 patients had dural tear.1 patient had misplaced implant.General complications ¿ postoperative complications within 1st follow-up year: 12 patients had infection.1 patient had thrombosis.Reoperations 1: 3 patients had adjustment of implant.1 patient had drain of hematoma.6 patients had drain of deep infection.1 patient had redecompression.5 patients had refusion.8 patients had removal of implant.2 patients had repair of dural injury.1 patient had reoperation to stop bleeding.5 patients had other unknown reoperations.Reoperation 2: 1 patient had drain of deep infection.1 patient had removal of implant.1 patient had other unknown reoperation.

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.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.

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.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: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 12547764
• MDR Text Key: 275406544
• Report Number: 8030965-2021-08121
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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?: No
• Date Manufacturer Received: 03/18/2024
• 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