MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	305010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the implant collapsed once we were final tightened.We had ap and lateral films of the implant expanded intro op.We also have ap and lateral films of the implant collapse once all the screws were all final tightened.We did not replace the cage.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment.The implant remains implanted and is unavailable for evaluation.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Because the implant was not returned for evaluation the root cause could not be determined conclusively.
Event or Problem Description
It was reported that; the implant collapsed once we were final tightened.We had ap and lateral films of the implant expanded intro op.We also have ap and lateral films of the implant collapse once all the screws were all final tightened.We did not replace the cage.

• Brand Name: ACCULIF TL 10-16 MM X 11 MM 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: 6234129
• Report Number: 3004024955-2017-00002
• Device Sequence Number: 889424
• Product Code: MAX
• UDI-Device Identifier: 07613327068061
• UDI-Public: (01)07613327068061
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: 305010
• Device Lot Number: 09251505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR