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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery using the inserter; it sliced the tubing on 2 separate tubing sets.On the third set, we were careful not to cut the tubing.After successfully expanding the implant, it collapsed intraoperatively after it was released from the inserter in-situ.Update (1-jun-2016): unexpanded cage was left implanted.Surgeon will monitor the patient.
Additional Manufacturer Narrative
Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported that the patient had particularly tight disk space.According to acculif surgical technique "if the endplate is violated, the surgeon user should collapse the implant (.).The surgeon should slowly re-expand the implant until it is just snug within the disc space.Be sure to check the expansion under fluoroscopy." conclusion: because the implant was not returned for evaluation the root cause could not be determined conclusively.
Event or Problem Description
It was reported that; during surgery using the inserter; it sliced the tubing on 2 separate tubing sets.On the third set, we were careful not to cut the tubing.After successfully expanding the implant, it collapsed intraoperatively after it was released from the inserter in-situ.Update ((b)(6) 2016): unexpanded cage was left implanted.Surgeon will monitor the patient.

• 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: 5740192
• Report Number: 3004024955-2016-00066
• Device Sequence Number: 506975
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: (01)07613327068054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/25/2016

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: 305008
• Device Lot Number: 07201508
• Was Device Available for Evaluation?: No
• 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: 09/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR