BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTER-TUBULAR PLATE 5 HOLES/41 MM A

    MDR report key: 509936 · Received February 5, 2004

    Report

    Report Number
    1719045-2004-00004
    Event Type
    Injury
    Date Received
    February 5, 2004
    Date of Event
    January 9, 2004
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THE PLATE, IMPLANTED IN 2003, BROKE POST-OPERATIVELY AND WAS EXPLANTED IN 2004. PT WAS BEING TREATED FOR PAINFUL ARTHRITIC LEFT GREAT TOE AND CLAW TOE LEFT, SECOND TOE. PT REPORTED FALLING IN 12/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUARTER-TUBULAR PLATE 5 HOLES/41 MM A STRAIGHT PLATES HRS SYNTHES (USA) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCREWS.