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 Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cage collapsed.
Additional Manufacturer Narrative
Method: visual inspection;device history review; complaint history review; risk assessment; results: a manufacturing review of the device was performed and indicated no discrepancies or anomalies.Materials analysis performed.X-rays were reviewed, it was confirmed that the implant reduced in height by approximately 2.818 mm.A visual inspection was performed on the returned device.The implant is still expanded to about 1 mm.Some scratches and discoloration were observed throughout the implant.These damages were most likely due to explanation and/or in-vivo use.Based on the information received from the sales rep, patient's bmi is 35.9 (obese).Height bmi may be one of the contributing factors of possible device failure.Conclusion: the root cause is not determined and is multifactorial.
Event or Problem Description
It was reported that the cage collapsed.

• 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: 5585487
• Report Number: 3004024955-2016-00045
• Device Sequence Number: 10827124
• Product Code: MAX
• UDI-Device Identifier: 07613327066777
• UDI-Public: (01)07613327066777
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2016

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: 0414509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2016
• Supplement Report FDA Received Date: 09/08/2016
• 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
• Patient Weight: 113