MAUDE Adverse Event Report: STRYKER SPINE-FRANCE NAVIGATOR 8MM X 26MM X 4DEG; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48392084
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	01/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the back rail of cage snapped off during the insertion and the inserter wing was found to be bent after the case.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to have a fractured back rail upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the plausible root cause of the reported event is a user error: too much force applied when implanting the implant.
Event or Problem Description
It was reported that the back rail of cage snapped off during the insertion and the inserter wing was found to be bent after the case.

• Brand Name: NAVIGATOR 8MM X 26MM X 4DEG
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5429092
• Report Number: 0009617544-2016-00055
• Device Sequence Number: 726329
• Product Code: MAX
• UDI-Device Identifier: 07613252252238
• UDI-Public: 07613252252238
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100865
• 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): 01/19/2016

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: 48392084
• Device Lot Number: 150194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2016
• Supplement Report FDA Received Date: 03/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1