MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	305008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; using an inserter which has been known to correctly expand cage they way it should, the cage was implanted at the l4-l5 level, expanded, and released from the inserter.Various fluoroscopy images were taken during this process.After completion of the level, the l5-s1 level was then prepared.Upon insertion of the cage at this level, a fluro shot was taken to confirm placement.It was at this time, approximately 10 minutes after it was inserted that we noticed that the cage had collapsed beyond the usual 1mm that might be acceptable to this implant.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.According to acculif surgical technique "if the endplate is violated, the surgeon user should collapse the implant (.).The surgeon should slowly re-expand the implant until it is just snug within the disc space.Be sure to check the expansion under fluoroscopy." conclusion: because the implant was not returned for evaluation the root cause could not be determined conclusively.
Event or Problem Description
It was reported that; using an inserter which has been known to correctly expand cage they way it should, the cage was implanted at the l4-l5 level, expanded, and released from the inserter.Various fluoroscopy images were taken during this process.After completion of the level, the l5-s1 level was then prepared.Upon insertion of the cage at this level, a fluro shot was taken to confirm placement.It was at this time, approximately 10 minutes after it was inserted that we noticed that the cage had collapsed beyond the usual 1mm that might be acceptable to this implant.

• Brand Name: ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5769465
• Report Number: 3004024955-2016-00070
• Device Sequence Number: 26236
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: (01)07613327068054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

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
• Operator of Device: No Information
• Device Catalogue Number: 305008
• Device Lot Number: 10261509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2016
• Supplement Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR