BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT

    MDR report key: 1360917 · Received April 14, 2009

    Report

    Report Number
    2183449-2009-00007
    Event Type
    Injury
    Date Received
    April 14, 2009
    Date of Event
    February 23, 2009
    Report Date
    April 10, 2009
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROVIDED INFORMATION STATES THE LENGTHENER STOPPED LENGTHENING AFTER 2.7CM DISTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT IMPLANTABLE LENGTHENER HSB ORTHOFIX INC. F12-300-380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention