BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 494985 · Received November 6, 2003

    Report

    Report Number
    2242816-2003-00015
    Event Type
    Malfunction
    Date Received
    November 6, 2003
    Report Date
    November 3, 2003
    Manufacturer
    EBI, L.P.
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBSEQUENT TO DEVICE APPLICATION THE BONE SCREW CLAMPS LOOSENED. ALLOWING THE ROD TO MOVE. BECAUSE THE PATIENT WAS SUFFICIENTLY HEALED, THE FIXATOR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX EXTERNAL FIXATION KTT EBI, L.P. 04250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other