MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS UNILIF SPACER 6 X 30 X 4DEG - 11MM; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48351064
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	03/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the graft broke into multiple pieces upon insertion.
Additional Manufacturer Narrative
Complaint history review; risk assessment; further email correspondence with sales rep confirmed surgeon used a mallet to insert the cage and noted that the disc space was tight.The surgical technique states to carefully insert the implant gently and progressively into the disc space.It is likely the force applied during insertion of the device into the tight disc space was excessive leading to the fracture implant.The plausible root cause of the reported event is user related.
Event or Problem Description
It was reported that the graft broke into multiple pieces upon insertion.

• Brand Name: AVS UNILIF SPACER 6 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: 5532455
• Report Number: 0009617544-2016-00137
• Device Sequence Number: 265501
• Product Code: MAX
• UDI-Device Identifier: 07613252015192
• UDI-Public: (01)07613252015192
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2016

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: 48351064
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2016
• Supplement Report FDA Received Date: 04/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1