BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLECRANON PLATE AND 3 SCREWS

    MDR report key: 1061742 · Received May 19, 2008

    Report

    Report Number
    1061742
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    March 20, 2008
    Report Date
    May 18, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH CREPITUS AND EDEMA AT IMPLANT SITE AND PAIN TO UPPER ARM. APPEARS SCREWS LOOSENED AND HAD TO BE REMOVED. HARDWARE REMOVED AND REPLACED WITH BONE MATRIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLECRANON PLATE AND 3 SCREWS HARDWARE, OLECRANON HRS CONMED CORPORATION NA 4-HOLE PROXIMAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR