BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR

    MDR report key: 2465755 · Received February 18, 2012

    Report

    Report Number
    3008524126-2012-00008
    Event Type
    Malfunction
    Date Received
    February 18, 2012
    Date of Event
    December 30, 2011
    Report Date
    February 16, 2012
    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

    INFORMATION PROVIDED STATES THAT THE TIBIAL LENGTHENER WAS IMPLANTED IN THE LEFT FEMUR OF THE PATIENT. IT WAS NOTICED THAT AFTER 14 DAYS THE LENGTHENER STOPPED DISTRACTING. THE UNIT WAS REMOVED AND REPLACED WITH A SAME SIZE LENGTHENER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other