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	10/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; during surgery, an implant collapsed after the surgeon had expanded it in a post-op mri.Update (b)(6) 2016 patient received a revision surgery.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: based on visual analysis the implant is unexpanded.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: a plausible root cause could not be identified.
Event or Problem Description
It was reported that; during surgery, an implant collapsed after the surgeon had expanded it in a post-op mri.Update 10/19/2016 patient received a revision surgery.

• 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: 6104708
• Report Number: 3004024955-2016-00104
• Device Sequence Number: 671887
• Product Code: MAX
• UDI-Device Identifier: 07613327066777
• UDI-Public: (01)07613327066777
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/26/2017

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: 400010
• Device Lot Number: 01271516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 01/26/2017
• 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