MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS UNILIF SPACER 7 X 30 X 4DEG - 11MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48351074
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; fracture of cage 7/30/4deg.
Additional Manufacturer Narrative
The device was inspected and was confirmed to be fractured.Upon device history review, no relevant manufacturing issues found.Most likely the device fractured due to excessive impaction force applied during insertion into tight disk space.
Event or Problem Description
It was reported that; fracture of cage 7/30/4deg.

• Brand Name: AVS UNILIF SPACER 7 X 30 X 4DEG - 11MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6775640
• Report Number: 0009617544-2017-00311
• Device Sequence Number: 13723235
• Product Code: MAX
• UDI-Device Identifier: 07613252015222
• UDI-Public: (01)07613252015222
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K090816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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 Model Number: 48351074
• Device Catalogue Number: 48351074
• Device Lot Number: RK2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR