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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant wouldn't expand.
Additional Manufacturer Narrative
Method: visual inspection,functional inspection, device history review, complaint history review, risk assessment; result: the devices were inspected visually and no visible damage was found.Functional test was performed on the returned devices.The devices functioned as intended when used outside of patient¿s body.The functionality related to in-vivo use could not be duplicated.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the plausible root cause of the reported event is most likely implant's position in collapsed disk space and/or releasing internal locking mechanism.
Event or Problem Description
It was reported that the implant wouldn't expand.

• 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: 6118452
• Report Number: 3004024955-2016-00105
• Device Sequence Number: 10857197
• Product Code: MAX
• UDI-Device Identifier: 07613327068030
• UDI-Public: (01)07613327068030
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 305006
• Device Lot Number: 12151520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1