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 Information (3190)
Date of Event	04/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cage collapsed.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the reported event of loss of height of the acculif cage was confirmed based on provided x-ray images.X-rays were reviewed by stryker r&d department and the reduction in height was measured.It was confirmed that the implant reduced in height by approximately 2.431 mm.A manufacturing review of the implanted device was performed and indicated no discrepancies or anomalies.Conclusion: the reported device remains implanted therefore a plausible root cause cannot be identified conclusively.
Event or Problem Description
It was reported that the cage collapsed.

• 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: 5665046
• Report Number: 3004024955-2016-00051
• Device Sequence Number: 431595
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: (01)07613327068054
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2016

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: 305008
• Device Lot Number: 01201503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 08/05/2016
• 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