BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON 3MX

    MDR report key: 1891920 · Received November 5, 2010

    Report

    Report Number
    2016150-2010-00186
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR'S OFFICE REPORTED THAT THE DE-BONDING OF A DAMON 3MX BRACKET IN A PATIENT CAUSED ENAMEL DELAMINATION. THE TOOTH WAS REPAIRED USING COMPOSITE AND THE PATIENT IS DOING FINE. THE DOCTOR STATED THAT THE ENAMEL DAMAGE MAY HAVE BEEN DUE TO HIS BRACKET REMOVAL TECHNIQUE. HE STATED THAT SINCE ADJUSTING HIS TECHNIQUE, HE HAS NOT ENCOUNTERED ANY FURTHER ENAMEL DELAMINATIONS WHEN DE-BONDING DAMON 3MX BRACKETS. THE BRACKET WAS NOT RETURNED TO ORMCO CORPORATION FOR EVALUATION; THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    ON OCTOBER 5, 2010, A DOCTOR REPORTED TO ORMCO CORPORATION THAT A PATIENT EXPERIENCED ENAMEL LOSS UPON DEBONDING A DAMON 3MX BRACKET. THIS IS THE SECOND OF FOUR REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAMON 3MX BRACKET, METAL, ORTHODONTIC EJF ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GRENGLOO