BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT

    MDR report key: 189205 · Received September 24, 1998

    Report

    Report Number
    2020467-1998-00006
    Event Type
    Injury
    Date Received
    September 24, 1998
    Date of Event
    May 15, 1997
    Report Date
    September 4, 1998
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT WAS USED TO BOND A HERBST APPLIANCE, AND THAT WHEN THE HERBST APPLIANCE WAS DEBONDED, A LINGUAL CUSP FRACTURED. PT'S DENTIST ADVISED ON 01-28-1998 THAT THE TOOTH REQUIRED A CROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT ORTHODONTIC BAND CEMENT DYH 3M UNITEK NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention ARCHWIRES. THERAPY DATES: 8/22/96 - 12/2/97.| HERBST APPLIANCE, ORTHODONTIC BRACKETS, BANDS,