BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-01608

    MDR report key: 3012814 · Received March 20, 2013

    Report

    Report Number
    2520274-2013-01608
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    October 1, 2010
    Manufacturer
    SYNTHES (USA) WEST CHESTER, PA
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ACTUAL EVENT DATE NOT KNOWN. EXACT PART NUMBER COULD NOT BE IDENTIFIED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT AND NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A N-HANCE - NFLEX PRESENTATION THAT ONE ROD BROKE FOLLOWING INTRA-OPERATIVE ROD DAMAGE DURING MANIPULATION OF DEGENERATIVE SCOLIOSIS. NO RE-INTERVENTION PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116487 MCV SYNTHES (USA) WEST CHESTER, PA

    Patients

    Seq Age Sex Outcome Treatment
    1