BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSTIQUE ROTH OVATION MANDIBULAR ARCH

    MDR report key: 532853 · Received July 2, 2004

    Report

    Report Number
    2418500-2004-00330
    Event Type
    Injury
    Date Received
    July 2, 2004
    Date of Event
    June 4, 2004
    Report Date
    June 4, 2004
    Manufacturer
    DENTSPLY GAC INTERNATIONAL, INC.
    Product Code
    NJM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S TOOTH ENAMEL WAS DAMAGED WHEN A MYSTIQUE BRACKET CAME LOOSE AND DEBONDED. FURTHER INVESTIGATION OF THIS EVENT REVEALED THAT THE ADHESIVE WAS TRANSBOND, NOT A DENTSPLY PRODUCT, THE TOOTH HAD BEEN PREVIOUSLY RESTORED BEFORE THE BRACKET WAS BONDED AND IMPROPER TOOTH SELECTION FOR THE BRACKET SIZE/TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYSTIQUE ROTH OVATION MANDIBULAR ARCH ORTHODONTIC PLASTIC BRACKET NJM DENTSPLY GAC INTERNATIONAL, INC. L1-2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention