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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	05/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the patient received a cage for a tlif and the cage collapsed postoperatively.Update (b)(6) 2016: spoke to the rep and he indicated that the cage has now backed out.Update (b)(6) 2016: the revision surgery performed on (b)(6) 2016 due implant migration.Patient did not report any pain prior the implant migration was noticed.
Additional Manufacturer Narrative
Method: visual analysis, complaint history review, device history review, risk assessment.Result: the reported event of loss of height of the cage was confirmed based on provided x-ray images.A visual inspection was performed on the returned device and no visual anomalies were identified.Slight scratches/discoloration throughout the implants was observed likely due to explantation damages and/or in vivo use.The device is still expanded to about 1 mm in height.A manufacturing review of the device was performed and indicated no discrepancies or anomalies.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; the patient received a cage for a tlif and the cage collapsed postoperatively.Update 6/16/2016: spoke to the rep and he indicated that the cage has now backed out.Update 6/20/2016: the revision surgery performed on (b)(6) 2016 due implant migration.Patient did not report any pain prior the implant migration was noticed.

• 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: 5740186
• Report Number: 3004024955-2016-00067
• Device Sequence Number: 10771385
• Product Code: MAX
• UDI-Device Identifier: 07613327066777
• UDI-Public: (01)07613327066777
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/25/2016

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: 400010
• Device Lot Number: 07201512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2016
• Supplement Report FDA Received Date: 09/08/2016
• 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: 33 YR