BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON 3MX

    MDR report key: 1267683 · Received December 19, 2008

    Report

    Report Number
    2016150-2008-00128
    Event Type
    Injury
    Date Received
    December 19, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR RESTORED THE PATIENT'S TOOTH USING A COMPOSITE RESTORATION AND BELIEVES THE PATIENT SHOULD BE FINE. HE REPORTED THAT HIS STAFF HAD DISCARDED THE ALLEGED BRACKET WITH ENAMEL FRACTURE, THEREFORE IT WOULD NOT BE RETURNED TO ORMCO CORPORATION FOR EVALUATION. THIS IS THE THIRD MDR REPORT OF THE FOUR INCIDENTS REPORTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR ALLEGED TO ORMCO CORPORATION THAT HE HAD FOUR PATIENT¿S RETURN WITH ENAMEL AND DENTIN FRACTURES ON THEIR SECOND PREMOLAR TEETH. ALL FOUR INCIDENTS OCCURRED WITH THE USE OF DAMON 3MX BRACKETS THAT HAD FALLEN OFF.

    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 13 YR Other