BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCISE ORTHODONTIC ADHESIVE

    MDR report key: 475262 · Received August 1, 2003

    Report

    Report Number
    2020467-2003-00002
    Event Type
    Injury
    Date Received
    August 1, 2003
    Date of Event
    July 22, 2003
    Report Date
    July 24, 2003
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT ENAMEL DAMAGE DOWN-TO-DENTIN, EXPOSING THE ROOT CANAL, OCCURRED ON PT'S LOWER RIGHT LATERAL TOOTH WHEN HE DEBONDED AN ORMCO ORTHODONTICS' STAINLESS STEEL BRACKET WHICH WAS BONDED WITH CONCISE ORTHODNTIC ADHESIVE. ORTHODONIST STATED THAT HE HAS USED THE ADHESIVE AND DEBONDING INSTRUMENT INVOLVED IN THIS EVENT FOR 20 YEARS WITHOUT MISHAP. PT'S TOOTH HAS BEEN REPAIRED WITH COMPOSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCISE ORTHODONTIC ADHESIVE ORTHODONTIC DYH 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 * Required Intervention BANDS| STAINLESS STEEL BRACKET #354-4062,| BRACKETS| BUCCAL TUBES| 3M UNITEK DEBRACKETING INSTRUMENT #444-761| ORMCO ORTHODONTICS' ALEXANDER SIGNATURE SERIES| ARCHWIRES