BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT

    MDR report key: 1231598 · Received November 13, 2008

    Report

    Report Number
    2183449-2008-00009
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    December 11, 2006
    Report Date
    November 13, 2008
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROVIDED INFO STATES THAT THE DEVICE, AFTER IMPLANTATION, PREMATURELY DISTRACTED 4 CENTIMETERS IN 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT IMPLANTABLE LENGTHENER HSB ORTHOFIX INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention