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

Catalog Number	48395090
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
(b)(4).The returned device was confirmed to be fractured.Upon device history review, all manufactured units met specification.No relevant manufacturing issues found.Conclusion: 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 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: 6455280
• Report Number: 0009617544-2017-00119
• Device Sequence Number: 477121
• Product Code: MAX
• UDI-Device Identifier: 07613252094630
• UDI-Public: (01)07613252094630
• 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: 48395090
• Device Lot Number: X4M
• 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