BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 227231 · Received June 8, 1999

    Report

    Report Number
    2242816-1999-00045
    Event Type
    Malfunction
    Date Received
    June 8, 1999
    Report Date
    June 7, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBSEQUENT TO DEVICE APPLICATION, WHILE THE PT WAS GETTING OUT OF BED SHE HEARD A "SNAP" AND NOTED ONE OF THE WIRE CARRIAGE BOLTS WAS BROKEN. IT WAS REPLACED IN THE MD'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. 13070 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other