BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM PROX FEMUR LCK PLATE 9H R 234MM

    MDR report key: 6134335 · Received November 30, 2016

    Report

    Report Number
    1020279-2016-00921
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 21, 2016
    Report Date
    May 2, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    PMA / PMN Number
    K072818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PFP PLATE BROKE WHILE IMPLANTED IN PATIENT. REVISION SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787380 4.5MM PROX FEMUR LCK PLATE 9H R 234MM PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 74800509 14GT43789

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R