MAUDE Adverse Event Report: STRYKER SPINE-FRANCE NAVIGATOR 11MM X 26MM X 0DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48392110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage broke off of inserter and was fixated 2/3 at l4/l5 of the patients spine.
Additional Manufacturer Narrative
Risk assessment; the device is still implanted and no lot number is available.Therefore, device evaluation, complaint history review and device history review could not be performed.The root cause of the reported event could not be determined without device evaluation.
Event or Problem Description
It was reported that the cage broke off of inserter and was fixated 2/3 at l4/l5 of the patients spine.

• Brand Name: NAVIGATOR 11MM X 26MM X 0DEG
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6302509
• Report Number: 0009617544-2017-00048
• Device Sequence Number: 16387508
• Product Code: MAX
• UDI-Device Identifier: 07613252252269
• UDI-Public: (01)07613252252269
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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: 48392110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR