MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL 8-12MM X 11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	400008
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon inserted cage into a disc space, expanded implant to 3/4 complete expansion.However, when he released the pressure the implant would drop back down to 8mm, the starting height.Expanding was attempted 2 different times and changed the o rings, it still wouldn't hold its expansion.Thus situation added an extra 5 minutes onto the case.Ended up opening a new implant and everything worked out great.
Additional Manufacturer Narrative
Visual inspection; functional inspection; device history review; complaint history review; risk assessment the cage was returned for analysis and no issues were found therefore the reported event cannot be confirmed.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.A plausible root cause could not be identified because no issues were found during functional inspection.
Event or Problem Description
It was reported that the surgeon inserted cage into a disc space, expanded implant to 3/4 complete expansion.However, when he released the pressure the implant would drop back down to 8mm, the starting height.Expanding was attempted 2 different times and changed the o rings, it still wouldn't hold its expansion.Thus situation added an extra 5 minutes onto the case.Ended up opening a new implant and everything worked out great.

• Brand Name: ACCULIF PL 8-12MM X 11MM 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: 5480313
• Report Number: 3004024955-2016-00021
• Device Sequence Number: 1135347
• Product Code: MAX
• UDI-Device Identifier: 07613327066760
• UDI-Public: 07613327066760
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2016

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: 400008
• Device Lot Number: 08261508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2016
• Supplement Report FDA Received Date: 05/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR