BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-CURE GLASS LONOMER BAND CEMENT

    MDR report key: 353294 · Received September 24, 2001

    Report

    Report Number
    2020467-2001-00006
    Event Type
    Injury
    Date Received
    September 24, 2001
    Date of Event
    August 23, 2001
    Report Date
    August 31, 2001
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT THEY HAD USED MULTI-CURE GLASS LONOMER ORTHODONTIC BAND CEMENT TO BOND STAINLESS STEEL CROWNS TO PATIENT'S MOLAR TEETH AND THEN TO ATTACH A HERBST APPLIANCE TO THE CROWN. UPON DEBONDING THE CROWN ON TOOTH #30 (LOWER RIGHT FIRST MOLAR), ONE OF THE CUSPS WAS REMOVED WHICH RESULTED IN EXPOSED DENTIN. THE TOOTH WAS REPAIRED WITH SEALANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43220 MULTI-CURE GLASS LONOMER BAND CEMENT ORTHODONTIC BAND CEMENT DYH 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention STAINLESS STEEL ORTHODONTIC BRACKETS, BANDS,| ARCHWIRES, ORTHODONTIC ADHESIVE, HERBST APPLIANCE.| THERAPY DATES: 1999 TO PRESENT.