BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 223903 · Received May 17, 1999

    Report

    Report Number
    2242816-1999-00022
    Event Type
    Malfunction
    Date Received
    May 17, 1999
    Report Date
    May 17, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS APPLIED TO TREAT A DISTAL RADIUS FRACTURE. APPROX 7 WEEKS POST APPLICATION, IT WAS NOTED THE FIXATOR WAS LOOSE ON THE BONE SCREWS. BECAUSE THE PT WAS SUFFICIENTLY HEALED, THE MD REMOVED THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATOR HTY ELECTRO-BIOLOGY, INC. 04001 052392

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other