BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 225353 · Received May 25, 1999

    Report

    Report Number
    2242816-1999-00038
    Event Type
    Malfunction
    Date Received
    May 25, 1999
    Date of Event
    May 16, 1999
    Report Date
    May 24, 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

    SUBSEQUENT TO DEVICE APPLICATION ONE OF THE WIRE CARRIAGES BROKE. IT WAS REPLACED WITHOUT INCIDENT.

    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