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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage only expanded a couple of mm then stopped.As the plunger was turned, it just kept spinning and nothing happened.The green indicator kept popping up and down but only to green.When the surgeon removed the syringe and tried to use another one, the syringe was stuck (could not remove from the inserter).After about ten minutes of manipulation, the syringe was able to be removed.A second syringe was then placed on the inserter and when expanding water was leaking out.The o ring was fine when checked, removed the o ring anyway and replaced with new one, and put the syringe back and same issue.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: visual and functional tests could not be performed as the implant was not returned and it remains implanted.Intra-op images showing the position of the cage are not available.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the root cause of the reported event is loss of pressure.
Event or Problem Description
It was reported that the cage only expanded a couple of mm then stopped.As the plunger was turned, it just kept spinning and nothing happened.The green indicator kept popping up and down but only to green.When the surgeon removed the syringe and tried to use another one, the syringe was stuck (could not remove from the inserter).After about ten minutes of manipulation, the syringe was able to be removed.A second syringe was then placed on the inserter and when expanding water was leaking out.The o ring was fine when checked, removed the o ring anyway and replaced with new one, and put the syringe back and same issue.

• 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: 5490212
• Report Number: 3004024955-2016-00028
• Device Sequence Number: 895278
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: (01)07613327068054
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/16/2016

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: 04271502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 07/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1