BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATOR 6MM X 26MM X 0DEG

    MDR report key: 2942813 · Received February 5, 2013

    Report

    Report Number
    0009617544-2013-00008
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MAX
    PMA / PMN Number
    K100865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AS IT WAS DISCARDED. LOT NUMBER IS UNKNOWN. REPORTED EVENT IS NOT CONFIRMED. WHILE WE SUSPECT IN THIS CASE THAT SURGEON HAD DIFFICULTIES TO INSERT THE IMPLANT IN THE DISC SPACE, BASED ON AVAILABLE DATA THE CAUSE OF THE BREAKAGE CANNOT BE DETERMINED. THE COMPLAINT CONDITION REMAINS UNKNOWN AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING IMPACTION OF INSERTER, REAR RAIL ON IMPLANT BROKE OFF CAUSING INSERTER TO BECOME DISENGAGED. THE IMPLANT WAS PARTIALLY IMPLANTED AND THE SURGEON WAS ABLE TO RETRIEVE IMPLANT WITH COCKER AND INSERT NEW IMPLANT WITHOUT INCIDENT." IT WAS LATER REPORTED THAT THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING IMPACTION OF INSERTER, REAR RAIL ON IMPLANT BROKE OFF CAUSING INSERTER TO BECOME DISENGAGED. THE IMPLANT WAS PARTIALLY IMPLANTED AND THE SURGEON WAS ABLE TO RETRIEVE IMPLANT WITH COCKER AND INSERT NEW IMPLANT WITHOUT INCIDENT." IT WAS LATER REPORTED THAT THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48629 NAVIGATOR 6MM X 26MM X 0DEG IMPLANT MAX STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR