MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL SPACER APPLICATOR HANDLE; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.001

Device Problem Device-Device Incompatibility (2919)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during a transforaminal lumbar interbody fusion (tlif) surgery, at the moment of implanting a transforaminal posterior atraumatic lumbar (t-pal) cage system, the cage remained stuck in the threaded rod of an unknown implant inserter and could not be released.The surgeon had difficulty removing the implant as it could not be released.Thus, the surgeon had to change the device to replace the cage.The surgical procedure had gone from a minimally invasive circumferential l4-l5 lumbar arthrodesis to an open l4-s1 arthrodesis, which increased the surgical delay for sixty to ninety (60-90) minutes.The surgical outcome was successful.This report is for one (1) t-pal spacer applicator handle.This is report 2 of 4 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.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: T-PAL SPACER APPLICATOR HANDLE
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8794700
• MDR Text Key: 151178537
• Report Number: 8030965-2019-66263
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819405813
• UDI-Public: (01)07611819405813
• Combination Product (y/n): N
• PMA/PMN Number: K151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 09/06/2019; 01/24/2020
• Supplement Dates FDA Received: 09/16/2019; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR