BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURE

    MDR report key: 481870 · Received September 5, 2003

    Report

    Report Number
    2418500-2003-00106
    Event Type
    Injury
    Date Received
    September 5, 2003
    Date of Event
    June 1, 2003
    Report Date
    July 11, 2003
    Manufacturer
    GAC
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DR REPORTED FRACTURING THE ENAMEL OF A PT'S TOOTH DURING THE DEBONDING OF AN ALLURE ORTHODONTIC BRACKET. THE PT WAS REFERRED TO A GENERAL DENTIST FOR ROOT CANAL THERAPY AND REBONDING OF THE ENAMEL. THE DR REPORTED USING REYBOND WITH FLOURIDE FOR CEMENTATION AND A UNITEK PLIER FOR REMOVING THE BRACKET, NEITHER OF WHICH ARE DENTSPLY PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURE ORTHODONTIC BRACKET DYW GAC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention