BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DE PUY

    MDR report key: 5159370 · Received February 19, 2004

    Report

    Report Number
    5159370
    Event Type
    Malfunction
    Date Received
    February 19, 2004
    Date of Event
    January 21, 2004
    Report Date
    January 26, 2004
    Manufacturer
    DE PUY
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARDWARE FAILURE OF LEFT TIB/FIB FRACTURE. TEN (10) - HOLE PLATE FRACTURED AND REQUIRED 2ND SURGICAL PROCEDURE TO REMOVE AND REPLACE SAME. MFR#: 1818910-2004-00176.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DE PUY 10-HOLE PLATE HRS DE PUY 1466-75-000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR