MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL 8-12MM X 11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	400008
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery occured for cage collapse.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Result: the reported event of loss of height of the cage cannot be confirmed.The x-rays were reviewed by stryker r&d department and based on x-rays quality the level of reduction in height (mm) was determined to be inconclusive.Conclusion: failure of the implant could not be confirmed conclusively therefore a plausible root cause could not be identified.
Event or Problem Description
It was reported that a revision surgery occured for cage collapse.

• Brand Name: ACCULIF PL 8-12MM X 11MM 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: 5721469
• Report Number: 3004024955-2016-00059
• Device Sequence Number: 10806631
• Product Code: MAX
• UDI-Device Identifier: 07613327066760
• UDI-Public: (01)07613327066760
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2016

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: 400008
• Device Lot Number: 02161503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 08/24/2016
• 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
• Patient Age: 22 YR