MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	305010
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; we, along with the surgeon, noticed that the implant had too much toggle on the inserter, which was locked appropriately upon insertion into the disc space.Upon examination we agreed, and determined the implant might not expand in situ with the toggle.For the safety of the patient and best possible outcome, we decided to test the inserter and implant on the sterile field by expanding the implant.It did expand, however, we determined the inserter components might be defective due to the excessive toggle of the implant on the inserter, as we have never seen this happen before, and file a per.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Visual inspection was performed and no visual anomalies were identified.No relevant manufacturing issues were identified as all released units met specifications the plausible root cause of the reported event cannot be identified conclusively.
Event or Problem Description
It was reported that; we, along with the surgeon, noticed that the implant had too much toggle on the inserter, which was locked appropriately upon insertion into the disc space.Upon examination we agreed, and determined the implant might not expand in situ with the toggle.For the safety of the patient and best possible outcome, we decided to test the inserter and implant on the sterile field by expanding the implant.It did expand, however, we determined the inserter components might be defective due to the excessive toggle of the implant on the inserter, as we have never seen this happen before, and file a per.

• Brand Name: ACCULIF TL 10-16 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: 6370588
• Report Number: 3004024955-2017-00014
• Device Sequence Number: 769233
• Product Code: MAX
• UDI-Device Identifier: 07613327068061
• UDI-Public: (01)07613327068061
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 305010
• Device Lot Number: 05201516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1