BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5013198 · Received August 19, 2015

    Report

    Report Number
    5013198
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 27, 2015
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CAME IN WITH A BROKEN PLATE IN THE FEMUR. THE HARDWARE WAS TAKEN OUT AND A ROD WAS PUT IN. THE OPERATING ROOM INFORMED THE COMPANY REP. I LEFT A MESSAGE WITH SYNTHES TO CALL ME BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546955 PLATE, FIXATION, BONE HRS SYNTHES (USA) PRODUCTS LLC 9277898

    Patients

    Seq Age Sex Outcome Treatment
    1 Other