BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE MOTION 3D COLORS CLASS II

    MDR report key: 10693786 · Received October 16, 2020

    Report

    Report Number
    2081322-2020-00001
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    January 9, 2020
    Report Date
    February 18, 2020
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    UDI-DI
    00190707023416
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO ORGANIZERS, INC. BECAME AWARE ON JANUARY 22ND, 2020 OF AN INCIDENT IN (B)(6) WHERE A PATIENT'S CROWN WAS BROKEN DURING THE REMOVAL OF A BONDED CARRIERE MOTION ORTHODONTIC APPLIANCE. ORTHO ORGANIZERS RECEIVED ADVERSE EVENT REVIEW QUESTIONNAIRE FILLED OUT BY THE DENTAL CLINIC IN QUESTION, THE PRACTICE OF (B)(6) DDS, (B)(6) ORTHODONTICS. MANUFACTURER REQUESTED LOT NUMBER AND/OR FOR THE DEVICE TO BE RETURNED FOR EVALUATION, BUT NEITHER WAS RECEIVED. FURTHER INVESTIGATION IS NOT POSSIBLE IN THIS CASE. TOOTH FRACTURE DURING DEBONDING IS SOMETHING THAT IS INHERENT TO ORTHODONTIC TREATMENT, AND CANNOT BE IMPLICITLY ATTRIBUTED TO A FAILURE OF THE DEVICE. INCIDENTS OF TOOTH FRACTURE RELATED TO DEBONDING OF CARRIERE MOTION 3D APPLIANCES WILL CONTINUE TO BE TRACKED BY THE COMPLAINT HANDLING PROCEDURE WITHIN THE ORTHO ORGANIZERS, INC. QUALITY MANAGEMENT SYSTEM.

    Description of Event or Problem · 1

    DOCTOR WAS REMOVING THE CARRIERE MOTION ORTHODONTIC APPLIANCE FROM THE PATIENT'S TOOTH AND THE INCISAL 1/3 OF THE CROWN BROKE OFF. NO PULP EXPOSURE BUT SHE WAS EXTREMELY SENSITIVE AND WILL NEED A CROWN. DOCTOR REMOVED THE APPLIANCE USING PIN AND LIGATURE CUTTERS AS THE PATIENT WAS BITING INTO A COTTON ROLL. SHE APPLIED PRESSURE FROM THE GINGIVAL AND OCCLUSAL, AND DID NOT TORQUE THE TOOTH. COMPLAINT RECEIVED BY ORTHO ORGANIZERS, INC. ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154851 CARRIERE MOTION 3D COLORS CLASS II ORTHODONTIC APPLIANCE EJF ORTHO ORGANIZERS, INC. 424-926RN 00190707023416

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention