BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY SKELETAL KENETIC DISTRACTOR

    MDR report key: 2231315 · Received July 25, 2011

    Report

    Report Number
    3008524126-2011-00020
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 2, 2011
    Manufacturer
    ORTHOFIX, INC.
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFO PROVIDED STATES THAT THE TIBIAL LENGTHENER WAS IMPLANTED IN THE RIGHT FEMUR. THE ISKD LENGTHENER STOPPED DISTRACTING AFTER 3 CM OF LENGTHENING. THE LENGTHENER WAS REMOVED AND REPLACED WITH ANOTHER LENGTHENER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMEDULLARY SKELETAL KENETIC DISTRACTOR ISKD LIMB LENGTHENER HSB ORTHOFIX, INC. T12-300-380

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other