BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER INC.

    MDR report key: 412341 · Received August 21, 2002

    Report

    Report Number
    MW1025940
    Event Type
    Malfunction
    Date Received
    August 21, 2002
    Date of Event
    August 13, 2002
    Report Date
    August 21, 2002
    Manufacturer
    ZIMMER INC.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCREW CAME OUT OF RONGUER DURING PROCEDURE AND FELL UNNOTICED INTO OPERATIVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER INC. PITUITARY RONGUER HTX ZIMMER INC. 3360 UNK NOT TO INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other