MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: T-PAL; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR

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  

Event Description

Device report from synthes reports an event in (b)(6) as follows: the current report is a retrospective analysis of 22 patients who underwent instrumentation with t-pal between january 02, 2006, and november 22, 2020.In 5 cases it was combined with expedium anterior.In 9 excluded cases it was combined with non-depuy anterior devices.This analysis is thus based on 13 cases.Mean age of the patients was (b)(6) years.Females were 64%.Intra-operative complications: 1 dural tear.Post-op complications within 1 year: 2 ssi superficial.Readmissions: 1 removal implant.This is for t-pal.This report is for one (1) unk - cage/spacers: t-pal.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - cage/spacers: t-pal/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Occupation: reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.

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.Updated event description updated manufacturer email updated 6.Health effect - clinical code 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

Updated: this is an updated evaluation of t-pal instrumentation based on 22 cases in the previous report and 1 more case operated between (b)(6) 2006 and (b)(6) 2022.On request we have reanalyzed the cohort including the 5 expedium anterior and 9 non-depuy anterior devices.Mean age of the patients was 52 years.Females were 65 percent.Intra-operative complications: -1 dural tear -1 infection post-op complications within 1 year: -2 infections reoperations: -1 implant removal this is for t-pal.This report is for one (1) unk - cage/spacers: t-pal this report captures intra-operative complications: -1 dural tear -1 infection this is report 1 of 2 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: T-PAL
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12739597
• MDR Text Key: 284995174
• Report Number: 8030965-2021-09222
• Device Sequence Number: 1
• Product Code: OVD
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/24/2023
• 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