BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXI XFIX DYNAFIX

    MDR report key: 157573 · Received March 13, 1998

    Report

    Report Number
    2242546-1998-00025
    Event Type
    Malfunction
    Date Received
    March 13, 1998
    Date of Event
    January 16, 1998
    Report Date
    March 12, 1998
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBSEQUENT TO DEVICE APPLICATION IT WAS NOTED THAT THE "C/D" MECHANISM WOULD NOT MOVE "PASSIVELY." AS PREVIOUSLY SCHEDULED, THE MD CHANGED THE FIXATOR. THERE WAS NO INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention