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
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); No Code Available (3191)
Date of Event	07/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient came to the surgeon's office with a report of bending and hearing a pop and muscle spasms (acculif collapse).At this point, no further surgical procedures are not required, but patient will be monitored.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assesment; result: the reported event of loss of height of the cage cannot be confirmed.The x-rays were not provided for evaluation therefore the level of reduction in height (mm) cannot be determined.A manufacturing review of the device was performed and indicated no discrepancies or anomalies of the reported device.Information regarding patient bmi, lifestyle and post-op activity level were not provided and cannot be evaluated.These may be contributing factors of early device failures.According to the instructions for use, patients involved in an occupation or activity that applies excessive loading upon the implant (e.G.Substantial walking, running, lifting, or muscle strain) may be at increased risk for failure of fusion and/or the device.Conclusion: failure of the implant could not be confirmed and therefore a plausible root cause could not be identified.
Event or Problem Description
It was reported that; patient came to the surgeon's office with a report of bending and hearing a pop and muscle spasms (acculif collapse).At this point, no further surgical procedures are not required, but patient will be 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: 5877161
• Report Number: 3004024955-2016-00076
• Device Sequence Number: 13519837
• Product Code: MAX
• UDI-Device Identifier: 07613327066760
• UDI-Public: (01)07613327066760
• Combination Product (Y/N): N
• 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): 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 400008
• Device Lot Number: 02161514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2016
• Supplement Report FDA Received Date: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other