MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL 10-16MM X11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	400010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/10/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; doctor was performing a revision alif and removed a cage that had collapsed.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: a manufacturing review of the device was performed and indicated no discrepancies or anomalies.Based on the fatigue testing results, the surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact the performance of the intervertebral body fusion device.Information regarding patient weight, lifestyle and post-op activity level is not available and cannot be evaluated.Conclusion: information regarding patient bmi, lifestyle and post-op activity level were not provided and cannot be evaluated.These may be contributing factors of early device failures.
Event or Problem Description
It was reported that; doctor was performing a revision alif and removed a cage that had collapsed.

• Brand Name: ACCULIF PL 10-16MM X11MM X 27 MM X 8 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5772014
• Report Number: 3004024955-2016-00071
• Device Sequence Number: 16627
• Product Code: MAX
• UDI-Device Identifier: 07613327066777
• UDI-Public: (01)07613327066777
• Combination Product (Y/N): N
• 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): 06/10/2016

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: 400010
• Device Lot Number: 04141508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention