MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS UNILIF WEDGENOSE VERTEBRAL SPACER 10X25X4-11; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48395104
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; 2 cages broke up while being implanted.
Additional Manufacturer Narrative
Lot# kkv; visual inspection; device history review; complaint history review; risk assessment.The returned device was confirmed to be fractured.Upon device history review, all manufactured units met specification.No relevant manufacturing issues found.The exact root cause could not be determined.
Event or Problem Description
It was reported that; 2 cages broke up while being implanted.

• Brand Name: AVS UNILIF WEDGENOSE VERTEBRAL SPACER 10X25X4-11
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6455284
• Report Number: 0009617544-2017-00120
• Device Sequence Number: 10881707
• Product Code: MAX
• UDI-Device Identifier: 07613252094661
• UDI-Public: (01)07613252094661
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/20/2017

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: 48395104
• Device Lot Number: KKV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1