BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 224513 · Received May 19, 1999

    Report

    Report Number
    2242816-1999-00028
    Event Type
    Malfunction
    Date Received
    May 19, 1999
    Date of Event
    March 1, 1999
    Report Date
    May 17, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 2 MONTHS AFTER THE FIXATOR WAS APPLIED FOR A TIBIA SHAFT FRACTURE, IT WAS REMOVED AS PREVIOUSLY SCHEDULE FOR A BONE GRAFT PROCEDURE. THE SAME FIXATOR WAS REAPPLIED AND IT WAS SUBSEQUENTLY NOTED ONE OF THE WIRE CARRIAGE BOLTS WAS BROKEN. THE BOLT WAS REPLACED WITHOUT INJURY TO THE PATIENT.

    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