MAUDE Adverse Event Report: SYNTHES GMBH T-PAL ADVANCED APPLICATOR HANDLE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 03.812.520

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during tlif surgery, a cage was inserted using new tpal set equipment.When the surgeon tried to disconnect the insertion device, he was unable to release the grip from the cage.Finally, after multiple attempts, the disconnection was completed, and the surgery was successfully completed.There was a surgical delay of fifteen (15) minutes.This report is for one (1) t-pal advanced applicator handle.This is report 1 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.H3, h6: narrative (functional issue) couldn't be verified from the provided pictures.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history (lot) part: 03.812.520, lot: l954903, manufacturing site: hägendorf, release to warehouse date: oct.05, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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

Additional event information related product complaint: (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.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part: 03.812.520.Lot: l954903.Manufacturing site: hägendorf.Release to warehouse date: oct.05, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 ADVANCED APPLICATOR HANDLE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10801661
• MDR Text Key: 215128392
• Report Number: 8030965-2020-08708
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07612334143778
• UDI-Public: (01)07612334143778
• Combination Product (y/n): N
• PMA/PMN Number: K181231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 12/04/2020; 01/05/2021
• Supplement Dates FDA Received: 12/30/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVANCED APPL INNER SHAFT; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL; ADVANCED APPL INNER SHAFT; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL