BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON 3MX

    MDR report key: 1357526 · Received April 8, 2009

    Report

    Report Number
    2016150-2009-00024
    Event Type
    Injury
    Date Received
    April 8, 2009
    Report Date
    March 10, 2009
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER INFORMATION WAS PROVIDED. A FOLLOW-UP REQUEST HAS BEEN MADE TO GET ADDITIONAL INFORMATION FROM THE DOCTORS AND TO RETURN THE PRODUCTS TO ORMCO CORPORATION FOR EVALUATION. THIS IS THE SECOND MDR REPORT OF THE TWO INCIDENTS REPORTED.

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT THE PATIENT'S TOOTH WAS REPAIRED USING AN UNKNOWN RESTORATION MATERIAL. THE DOCTOR REPORTED THAT THE PATIENT'S TOOTH IS NOW DOING FINE. THE DOCTOR REPORTED THAT SHE DISCARDED THE BRACKET INVOLVED IN THE ALLEGED INCIDENT AND WILL NOT RETURN THE BRACKET TO ORMCO CORPORATION. THEREFORE, NO EVALUATION WILL BE PERFORMED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2009, TWO DOCTORS ALLEGED TO ORMCO CORPORATION THAT THEY HAD TOOTH BREAKAGES IN TWO DIFFERENT PATIENTS FROM THE DEBONDING OF ORTHODONTIC DAMON 3MX BRACKETS THAT HAD BEEN CEMENTED USING GRENGLOO DENTAL CEMENT. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON MARCH 10, 2009, A DOCTOR ALLEGED TO ORMCO CORPORATION THAT A PATIENT'S TOOTH #31 BROKE AFTER THE DEBONDING OF AN ORTHODONTIC DAMON 3MX BRACKET THAT HAD BEEN CEMENTED USING GRENGLOO DENTAL CEMENT.

    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 12 YR Other| R