BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 240495 · Received September 15, 1999

    Report

    Report Number
    2242816-1999-00055
    Event Type
    Injury
    Date Received
    September 15, 1999
    Report Date
    September 15, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS APPLIED ON 07/23/1999 TO TREAT A DISTAL RADIUS FRACTURE. THE FIXATOR SUBSEQUENTLY LOOSENED AND THE PT SUSTAINED A LOSS OF REDUCTION. THE FIXATOR WAS RETIGHTENED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. 04003 085817

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention