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	09/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an expandable cage would not expand.No leakage at syringe or syringe/inserter interface.No pressure observed at inserter gauge.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the root cause of this event cannot be determined conclusively because the cage was not returned for evaluation.
Event or Problem Description
It was reported that an expandable cage would not expand.No leakage at syringe or syringe/inserter interface.No pressure observed at inserter gauge.

• 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: 6055205
• Report Number: 3004024955-2016-00096
• Device Sequence Number: 347830
• Product Code: MAX
• UDI-Device Identifier: 07613327068030
• UDI-Public: (01)07613327068030
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/30/2016

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: 305006
• Device Lot Number: 09231503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR