MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 6-9 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	305006
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; post op evaluation of a patient, shows implant is migrating posteriorly and revision surgery is required.The cage appears to still be expanded.
Additional Manufacturer Narrative
A manufacturing review was performed and indicated no discrepancies or anomalies.Visual inspection shows the returned device is still expanded.The root cause of the reported event cannot be determine conclusively.
Event or Problem Description
It was reported that; post op evaluation of a patient, shows implant is migrating posteriorly and revision surgery is required.The cage appears to still be expanded.

• Brand Name: ACCULIF TL 6-9 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: 6254418
• Report Number: 3004024955-2017-00006
• Device Sequence Number: 19050995
• Product Code: MAX
• UDI-Device Identifier: 07613327068030
• UDI-Public: (01)07613327068030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: 305006
• Device Lot Number: 11121515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 03/24/2017
• 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: Required Intervention