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
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	03/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; original dos (b)(6) 2016, on (b)(6) 2016 patient presented x-rays taken "possible device collapsed", revision surgery done on (b)(6) 2016.Device removed, unknown whether it had collapsed.Implant finally obtained from risk management on (b)(6) 2016.Additional information: patient came for a follow up visit 2 weeks after the surgery and x-rays revealed vertebral body fracture.The implant was still expanded.According to sales rep, cage loss in height approximately 1 mm.
Additional Manufacturer Narrative
Results: the reported event of post-op loss of height of the cage cannot be confirmed.Visual inspection of the explanted device was performed and revealed that the implant is still expanded approximately 2 mm.According to the sales rep doctor seems to believe that the implant settled 1 mm and locked.Per acculif surgical technique, if the implant was not fully expanded to the next millimeter increment, the implant will settle back down to the lower millimeter increment.Settling up to1mm is normal and does not indicate a failure of the device.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; original dos (b)(6) 2016, on (b)(6) 2016 patient presented x-rays taken "possible device collapsed", revision surgery done on (b)(6) 2016.Device removed, unknown whether it had collapsed.Implant finally obtained from risk management on (b)(6) 2016.Additional information: patient came for a follow up visit 2 weeks after the surgery and x-rays revealed vertebral body fracture.The implant was still expanded.According to sales rep, cage loss in height approximately 1 mm.

• 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: 5568662
• Report Number: 3004024955-2016-00043
• Device Sequence Number: 517811
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: (01)07613327068054
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2016

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: 04141506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2016
• Supplement Report FDA Received Date: 08/04/2016
• 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 Weight: 159