BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORS DIST RADIUS-RT WIDE

    MDR report key: 278429 · Received May 19, 2000

    Report

    Report Number
    1818910-2000-00124
    Event Type
    Malfunction
    Date Received
    May 19, 2000
    Date of Event
    March 1, 2000
    Report Date
    May 19, 2000
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REMOVED THE PLATE AND SCREWS AFTER THE FRACTURE WAS FULLY HEALED. THE SURGEON FOUND METAL SHAVINGS APPROXIMATELY 1.0 CM LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORS DIST RADIUS-RT WIDE FIXATION PROSTHESIS HRS DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other