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 Problem (1384)
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; surgeon notified sales rep that the cage he implanted on (b)(6) 2016 has collapsed.Details and x-rays are in attached documents.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.A manufacturing review was performed on the reported lot and indicated no discrepancies or anomalies.The reported device remains implanted therefore a plausible root cause cannot be identified conclusively.
Event or Problem Description
It was reported that; surgeon notified sales rep that the cage he implanted on (b)(6) 2016 has collapsed.Details and x-rays are in attached documents.

• 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: 6084339
• Report Number: 3004024955-2016-00098
• Device Sequence Number: 1602556
• Product Code: MAX
• UDI-Device Identifier: 07613327068061
• UDI-Public: (01)07613327068061
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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
• Operator of Device: No Information
• Device Catalogue Number: 305010
• Device Lot Number: 10201505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR