BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTGLASS

    MDR report key: 432806 · Received December 10, 2002

    Report

    Report Number
    MW1026980
    Event Type
    Malfunction
    Date Received
    December 10, 2002
    Date of Event
    February 15, 1997
    Report Date
    December 10, 2002
    Manufacturer
    HERAEUS KULZER INC.
    Product Code
    DZN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REPORTER PLACED THREE ARTGLASS CROWNS FOR A PT. THEY WERE MADE BY A LABORATORY AND WERE FABRICATED WITH HIGH NOBLE GOLD. THESE CROWNS WERE MADE OF ARTGLASS AND WERE REPUTED TO BE OF THE FINEST MATERIAL AND VERY QUICKLY, WITHIN ONE YEAR SERIOUS PROBLEMS DEVELOPED WHICH LED TO THE REPLACEMENT OF ALL THREE CROWNS FOR THIS PT. REPORTER JUST READ ABOUT THESE PROBLEMS IN THE ADA NEWSLETTER RECENTLY AND DISCOVERED THAT THIS IS A PROBLEM WITH MANY DENTISTS THROUGHOUT THE COUNTRY. REPORTER FEELS PRODUCT WAS MISREPRESENTED BY HERAEUS KULZER INC. AND REPORTER BELIEVES HAS BEEN TAKEN OFF THE MARKET. THIS PT SUFFERED UNECESSARY DENTAL TREATMENT AND THE LOSS OF TIME FROM WORK AND THE FINANCIAL LOSS OF HAVING TO REPLACE THESE CROWNS AT ANOTHER OFFICE, AS REPORTER IS NO LONGER CARING FOR THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTGLASS DENTAL MATERIALS FOR CROWNS DZN HERAEUS KULZER INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other