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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon regular post op visit, the cage collapse was noticed.There are no revisions planned, patient is being monitored.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: the acculif surgical technique provides detailed instructions on how to confirm that the implant is securely expanded and locked in the expanded position during initial surgery.These techniques include: tactile force applied to the insertion handle which is still attached to the implant, the pressure gauge on the syringe with a color-coded pressure indicator, direct visualization of the expanded implant in the disc space and the use of fluoroscopic imaging.Conclusion: the reported device remains implanted therefore a plausible root cause cannot be identified conclusively.
Event or Problem Description
It was reported that upon regular post op visit, the cage collapse was noticed.There are no revisions planned, patient is being monitored.

• 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: 5486225
• Report Number: 3004024955-2016-00025
• Device Sequence Number: 13549006
• Product Code: MAX
• UDI-Device Identifier: 07613327066760
• UDI-Public: 07613327066760
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2016

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: 02161510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 07/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR