BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORELAND CEMENT REMOVAL INSTRUMENT

    MDR report key: 566627 · Received December 27, 2004

    Report

    Report Number
    MW1034339
    Event Type
    Malfunction
    Date Received
    December 27, 2004
    Report Date
    December 22, 2004
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER OF INSRUMENT TRAYS ARE PROVIDING UNACCEPTABLE STERILIZATION INSTRUCTIONS FOR STANDARD HOSP STERILIZATION CYCLES. SOME COMPANIES ARE NOT ABLE TO PROVIDE STERILIZATION INSTRUCTIONS IN WRITING WHEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORELAND CEMENT REMOVAL INSTRUMENT STERILIZATION INSTRUCTIONS LZV DEPUY ORTHOPAEDICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *