BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT

    MDR report key: 925986 · Received October 10, 2007

    Report

    Report Number
    2183449-2007-00025
    Event Type
    Injury
    Date Received
    October 10, 2007
    Date of Event
    June 25, 2007
    Report Date
    October 9, 2007
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ISKD LENGTHENER WAS IMPLANTED IN THE PATIENT'S RIGHT FEMUR IN 2007. AT THE ONE WEEK FOLLOW-UP POST-OP VISIT, THE DOCTOR NOTED THAT THE PATIENT HAD NOT ACHIEVED ANY LENGTH AND DETERMINED THAT THE OSTEOTOMY SITE HAD PREMATURELY CONSOLIDATED. A SECOND SURGERY WAS PERFORMED SO THAT ANOTHER OSTEOTOMY COULD BE DONE TO ALLOW MOVEMENT TO THE LENGTHENER. THE DOCTOR THEN DETERMINED THAT THE LENGTHENER WAS NOT FUNCTIONING AS INTENDED (LENGTHENING), SO THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT IMPLANTABLE LENGTHENER HSB ORTHOFIX INC. F12-255-305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability