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 Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown opal cage/spacers/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 318 patients (mean age of 58 years) who underwent matrix instrumentation, 21 of these had opal anterior.The following complications have been identified as per the swedish spine registry (swespine) report: general complications - intraoperative complications 2 death.11 dural tear.4 misplaced implant.2 root injury.General complications - postoperative complications within index hospitalization 6 ssi deep.16 ssi superficial.2 thrombosis.5 underwent reintervention during stay: removal of implant (n=1), repair of dural injury (n=1), replacement of implant (n=4).Readmissions readmission 1: 1 adjustment of implant.1 drain of infection.2 drain of deep infection.2 drain of hematoma.9 refusion.2 removal of implant.1 repair of dural injury.1 revision of fusion.Readmission 2: 1 drain deep infection.1 removal of implant.Readmission 3: 1 removal of implant.This is for depuy synthes opal cage/spacers.It captures the reported events of 1 adjustment of implant, 1 drain of infection, 3 drain of deep infection, 2 drain of hematoma, 9 refusion, 4 removal of implant, 1 repair of dural injury and 1 revision of fusion.This is report 5 of 8 for (b)(4).

Event Description

Updated 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 338 patients who underwent matrix instrumentation.14 cases were excluded because of combination with anterior non-depuy implants.The remaining 324 cases include 21 opal anterior.Mean age was 58 years.The following complications have been identified as per the swedish spine registry (swespine) report: intraoperative complications (n=20).N=2 death.N=12 dural tear.N=4 misplaced implant.N=2 root injury.Postoperative complications within 1 year (n=27) n=1 pulmonary embolism.N=24 infection.N=2 thrombosis.Reoperations (26 patients underwent reoperations for complications, with a total of 29 registered reoperations) reoperation 1: n=5 for adjustment of implant.N=3 for drain of infection.N=2 for drain of hematoma.N=10 for refusion.N=4 removal of implant.N=2 repair of dural injury.Reoperation 2: n=1 for drain deep infection.N=1 removal of implant.Reoperation 3 n=1 removal of implant.

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.

• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12416434
• MDR Text Key: 273319930
• Report Number: 8030965-2021-07457
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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: 02/09/2023
• 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