MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER 10MM X 28MM 7MM HEIGHT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number 08.812.007

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

Device malfunctioned intra-operatively and was not implanted / explanted.(b)(4).Dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 15.April 2011.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

It was reported that during a surgery on (b)(6) 2017 when a surgeon took a mallet and tapped the top of the insertion device to advance the implant into the desired location he realized the transforaminal posterior atraumatic lumbar (t-pal) spacer 10mm x 28mm 7mm height had broken into two pieces.One small piece remained attached to the inserter and the other broken piece was removed from the disc space.The surgeon then inserted a synthes opal spacer into the disc space instead of trying another t-pal.There was a surgical delay of 25minutes.The surgery was successfully completed with patient in stable condition.Concomitant devices reported: t-pal spacer applicator handle (part 03.812.001, lot 3409318, quantity 1).This report is for one (1) t-pal spacer 10mm x 28mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.The investigation summary indicates that: a t-pal spacer 10mm x 28mm 7mm height (08.812.007 lot 3735345) broken intra-operatively during insertion; all fragments retrieved.The procedure was able to be completed by implanting an opal spacer after a 25 minute surgical delay.The returned spacer was examined and the complaint condition was able to be confirmed as the device was found to be broken into two pieces.No definitive root cause could be determined, however the failure is likely the result of attempting to insert an implant that is too large for the distracted space.This could be the result of incorrect implant selection, incomplete endplate preparation or insufficient anatomical restoration through distraction.Replication is not applicable, as the device is already broken.A device history review, including material review, was performed for the returned implant¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.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 10MM X 28MM 7MM HEIGHT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6992272
• MDR Text Key: 90738825
• Report Number: 3003875359-2017-10543
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10705034759524
• UDI-Public: (01)10705034759524(10)3735345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08.812.007
• Device Catalogue Number: 08.812.007
• Device Lot Number: 3735345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 55