BEUDAMED
    FDA Adverse Event Summary report: N

    NI

    MDR report key: 1069331 · Received July 3, 2008

    Report

    Report Number
    1719045-2008-00081
    Date Received
    July 3, 2008
    Report Date
    June 4, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    NQP
    PMA / PMN Number
    K061774
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURE DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SURGEON ADVISED TWO NFIX RODS, IMPLANTED ON AN UNKNOWN DATE, WERE NOTED AS BROKEN FOLLOWING PATIENT'S INVOLVEMENT IN A MOTOR VEHICLE ACCIDENT. FILMS SHOW THE RODS TO BE INTACT PRIOR TO THE MVA AND BROKEN AFTER THE MVA. PT BEGAN TO COMPLAIN OF BACK PAIN IMMEDIATELY AFTER THE ACCIDENT. SURGEON PLANS REMOVAL OF RODS WITH REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI N FIX II RODS NQP SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention