BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ART GLASS - HERAEUS KULZER

    MDR report key: 440506 · Received January 28, 2003

    Report

    Report Number
    MW1027228
    Event Type
    Injury
    Date Received
    January 28, 2003
    Report Date
    January 28, 2003
    Manufacturer
    HERAEUS KULZER INC.
    Product Code
    DZN
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL PT HAD AN "ART GLASS" TO METAL CROWN ON THEIR LOWER RIGHT FIRST PREMOLAR PLACED IN 7/1997. THE ART GLASS MATERIAL DEBONDED IN 2001, REQUIRING REPLACEMENT OF THE CROWN WITH A MORE SUITABLE MATERIAL. HAD THIS NOT BEEN DONE, THE TOOTH WOULD HAVE SUPER ERUPTED, POSSIBLY REQUIRING REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ART GLASS - HERAEUS KULZER * DZN HERAEUS KULZER INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention