BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON 3MX

    MDR report key: 1231450 · Received November 17, 2008

    Report

    Report Number
    2016150-2008-00111
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR RESTORED THE PATIENT'S UPPER LEFT CUSPID TOOTH WITH A COMPOSITE MATERIAL AND CONFIRMED THAT THE TOOTH WOULD BE FINE. THE DOCTOR REFERRED THE PATIENT TO HER REGULAR DENTIST FOR THE UPPER RIGHT FIRST BICUSPID TO REPAIR THE BROKEN TOOTH. THE ACTUAL DEVICE INVOLVED IN THIS INCIDENT WAS RETURNED TO ORMCO CORPORATION FOR EVALUATION. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR REPORTED TO ORMCO CORPORATION THAT WHEN HIS DENTAL ASSISTANT DEBONDED A DAMON 3MX BRACKET FROM A PATIENT'S UPPER RIGHT FIRST BICUSPID USING A DEBONDING PLIER THE BUCCAL PORTION OF THE TOOTH BROKE OFF WITH THE BRACKET. THE DOCTOR ALSO REPORTED THAT A VERY SMALL PIECE OF ENAMEL ALSO BROKE OFF THE PATIENT¿S UPPER LEFT CUSPID DURING BRACKET REMOVAL.

    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 33 YR Other