BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 1062437 · Received June 10, 2008

    Report

    Report Number
    1062437
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 10, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONMED LINVATEC BONE SHAVERS - NOTED SHREDS OF METAL AFTER USE, PATIENT'S KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED SHAVER, ARTHROSCOPIC HXZ CONMED LINVATEC C9284 & P9366 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR