BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 224412 · Received May 18, 1999

    Report

    Report Number
    2242816-1999-00024
    Event Type
    Malfunction
    Date Received
    May 18, 1999
    Date of Event
    May 10, 1999
    Report Date
    May 18, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE MOVING BACK INTO BED FROM A CHAIR, THE PT HEARD A NOISE AND NOTED ONE OF THE WIRE CARRIAGE BOLTS WAS BROKEN. THE ENTIRE WIRE CARRIAGE WAS REPLACED. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. 13070 052877

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other