MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS UNILIF WEDGENOSE VERTEBRAL SPACER 9X25X0-11; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48395090
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon intended on placing the cage at l5/s1.He hit the inserter repeatedly with a mallet.The cage was not advancing.When he pulled it out it had broken.All pieces were recovered.
Additional Manufacturer Narrative
Method: risk assesment.Result: the reported event was confirmed via stryker sales rep.The device was not returned and lot number was not provided, therefore device inspection, manufacturing history review and complaint history review could not be performed.Conclusion: since the product is not returned and device evaluation is not performed, the root cause of the reported product issue is inconclusive and multifactorial.
Event or Problem Description
It was reported that; the surgeon intended on placing the cage at l5/s1.He hit the inserter repeatedly with a mallet.The cage was not advancing.When he pulled it out it had broken.All pieces were recovered.

• Brand Name: AVS UNILIF WEDGENOSE VERTEBRAL SPACER 9X25X0-11
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5732297
• Report Number: 0009617544-2016-00241
• Device Sequence Number: 18838144
• Product Code: MAX
• UDI-Device Identifier: 07613252094623
• UDI-Public: (01)07613252094623
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093704
• 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): 05/25/2016

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: 48395090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2016
• Supplement Report FDA Received Date: 08/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1