BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT

    MDR report key: 873354 · Received June 29, 2007

    Report

    Report Number
    2183449-2007-00014
    Event Type
    Injury
    Date Received
    June 29, 2007
    Date of Event
    June 21, 2007
    Report Date
    June 29, 2007
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ISKD LENGTHENER WAS IMPLANTED IN 2006. IN 2007, THE ISKD LENGTHENER BROKE IN SITU. THE DOCTOR NOTED THAT THE PATIENT HAD DEVELOPED A NON-UNION OF THE TREATMENT SITE. THE ISKD LENGTHENER WAS REPLACED WITH A NAIL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention