BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE MOTION 3D COLORS CLASS II

    MDR report key: 13113070 · Received December 29, 2021

    Report

    Report Number
    2081322-2021-00002
    Event Type
    Injury
    Date Received
    December 29, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    UDI-DI
    00190707023096
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 3RD, 2021, ORTHO ORGANIZERS, INC. BECAME AWARE OF AN ADVERSE EVENT INVOLVING THE CARRIERE MOTION 3D COLOR CLASS II APPLIANCE. THE COMPLAINT RECEIVED FROM THE CLINICIAN STATES THAT UPON DEBONDING OF A CARRIERE MOTION 3D COLOR CLASS II 16 MM (SILVER) DEVICE BY THE DOCTOR'S ASSISTANT, THE (B)(6) FEMALE PATIENT EXPERIENCED SHEARING OF THE FACIAL SURFACES OF BOTH UPPER CANINE TEETH (TEETH # 6 AND 11). THE DEVICE WAS NOT SAVED BY THE ORTHODONTICS OFFICE AND THUS COULD NOT BE RETURNED TO ORTHO ORGANIZERS FOR INVESTIGATION. THE PATIENT QUESTIONNAIRE WAS NOT RETURNED TO US, EVEN AFTER SEVERAL ATTEMPTS OF CONTACTING THE DOCTOR'S OFFICE.

    Description of Event or Problem · 0

    UPON DEBONDING OF A CARRIERE MOTION 3D COLOR CLASS II 16 MM (SILVER) DEVICE BY THE DOCTOR'S ASSISTANT, THE (B)(6) FEMALE PATIENT EXPERIENCED SHEARING OF THE FACIAL SURFACES OF BOTH UPPER CANINE TEETH (TEETH # 6 AND 11). ACCORDING TO THE DOCTOR'S COMPLAINT, THE 3D MOTION DEVICE HAD BEEN ATTACHED TO THE ETCHED CANINES WITH TRANSBOND ADHESIVE BOND MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008579 CARRIERE MOTION 3D COLORS CLASS II ORTHODONTIC APPLIANCE EJF ORTHO ORGANIZERS, INC. 424-916CN 00190707023096

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Disability