MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL 10-16MM X11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	400010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; collapse noticed on follow up visit xray.Update: (b)(6) 2106 - mild back pain.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.A manufacturing review of the device was performed and indicated no discrepancies or anomalies.Based on the fatigue testing results, the surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact the performance of the intervertebral body fusion device.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G.Substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.Information regarding patient weight, lifestyle and post-op activity level is not available and cannot be evaluated.The reported device remains implanted therefore a plausible root cause cannot be identified conclusively.
Event or Problem Description
It was reported that; collapse noticed on follow up visit xray.Update: (b)(6) 2106 - mild back pain.

• Brand Name: ACCULIF PL 10-16MM X11MM 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: 5991949
• Report Number: 3004024955-2016-00090
• Device Sequence Number: 570565
• Product Code: MAX
• UDI-Device Identifier: 07613327066777
• UDI-Public: (01)07613327066777
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132507
• 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): 09/06/2016

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: 400010
• Device Lot Number: 07201512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 11/29/2016
• 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