MAUDE Adverse Event Report: STRYKER SPINE-FRANCE NAVIGATOR 10MM X 26MM X 4DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48392104
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	02/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon impaction of the cage the rail broke off where it interfaces with the inserter.
Additional Manufacturer Narrative
Visual inspection; functional inspection; device history review; complaint history review; risk assessment; a materials analysis performed on a similar investigation concluded that the cage broke in fast fracture indicating the fracture resulted from a sudden overload applied to the device.It was reported that this implant broke during impaction.Probable root cause is due to user error: too much force applied when implanting the implant.
Event or Problem Description
It was reported that; upon impaction of the cage the rail broke off where it interfaces with the inserter.

• Brand Name: NAVIGATOR 10MM 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: 5514930
• Report Number: 0009617544-2016-00126
• Device Sequence Number: 1162789
• Product Code: MAX
• UDI-Device Identifier: 07613252252252
• UDI-Public: (01)07613252252252
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K100865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2016

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: 48392104
• Device Lot Number: 12A030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• 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
• Patient Age: 59 YR