BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 48912 · Received November 11, 1996

    Report

    Report Number
    2242546-1996-00097
    Event Type
    Injury
    Date Received
    November 11, 1996
    Date of Event
    September 1, 1996
    Report Date
    November 8, 1996
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MD APPLIED FIXATOR TO TREAT A FRACTURED FEMUR. SUBSEQUENTLY IT WAS NOTED THAT HTE FIXATOR LOST REDUCTION. A SECOND SURGERY WAS PERFORMED TO REPLACE THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. 02000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention