MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	305010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	09/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the cage collapsed.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment.The x-rays provided by the sales rep were reviewed by stryker r&d department.Based on orientation/quality of the images, the level of height reduction cannot be confirmed.Additional ap x-rays were requested from the sales rep however they were not received.The cage remains implanted.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Failure of the implant could not be confirmed conclusively therefore a plausible root cause could not be identified.
Event or Problem Description
It was reported that; the cage collapsed.

• Brand Name: ACCULIF TL 10-16 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: 6015143
• Report Number: 0009617544-2016-00406
• Device Sequence Number: 39859
• Product Code: MAX
• UDI-Device Identifier: 07613327068061
• UDI-Public: (01)07613327068061
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/13/2016

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: 305010
• Device Lot Number: 04091503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2016
• Supplement Report FDA Received Date: 12/15/2016
• 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