MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS UNILIF SPACER 9 X 33 X 4DEG - 11MM; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48353094
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage snapped in half upon insertion.
Additional Manufacturer Narrative
Lot# te3; visual inspection, device history review, complaint history review, risk assessment.The returned device was confirmed to be fractured.Upon device history review, no relevant manufacturing issues found.It is likely that the device fractured due to too much impaction force applied during insertion.
Event or Problem Description
It was reported that the cage snapped in half upon insertion.

• Brand Name: AVS UNILIF SPACER 9 X 33 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: 6169781
• Report Number: 0009617544-2016-00491
• Device Sequence Number: 13498885
• Product Code: MAX
• UDI-Device Identifier: 07613252015307
• UDI-Public: (01)07613252015307
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2017

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 Catalogue Number: 48353094
• Device Lot Number: TE3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1