BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 225107 · Received May 24, 1999

    Report

    Report Number
    2242816-1999-00034
    Event Type
    Malfunction
    Date Received
    May 24, 1999
    Report Date
    May 24, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROX TWO WEEKS AFTER DEVICE APPLICATION IT WAS NOTED ONE OF THE SCREW CARRIAGES WAS BROKEN. THE CARRIAGE WAS REPLACED WITHOUT INCIDENT. TWO "LATERS" LATER A SECOND SCREW CARRIAGE BROKE. THIS WAS ALSO REPLACED WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PATIENT. IT SHOULD BE NOTED THAT THE PATIENT IS WEIGHTBEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other