BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE MOTION CLASS II

    MDR report key: 6599788 · Received May 30, 2017

    Report

    Report Number
    2081322-2017-00002
    Event Type
    Injury
    Date Received
    May 30, 2017
    Date of Event
    May 1, 2017
    Report Date
    May 1, 2017
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    UDI-DI
    00190707023362
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORTHODONTIST REMOVED AS MUCH COMPOSITE AS POSSIBLE AROUND UL3, UL6, UR4 AND UR6. ONCE THE EXCESS COMPOSITE WAS REMOVED, THE DENTAL ASSISTANT USED A BRACKET REMOVING PLIER AND SQUEEZED BETWEEN THE BONDING PAD AND TOOTH. A 1MM OF INCISAL ENAMEL UL3 WAS FRACTURED. A SMALL AMOUNT OF FLOWABLE COMPOSITE RESIN WAS BONDED TO THE ENAMEL FRACTURE. BECAUSE THE APPLIANCE WAS BONDED TO THE VERY INCISAL EDGE OF THE FACIAL SURFACE, THE ORTHODONTIST THOUGHT THE ENAMEL MAY HAVE BEEN TOO BRITTLE AT THE EDGE OF THE TOOTH. ADDITIONALLY, THE ORTHODONTIST SWITCHED THE BONDING AGENTS APPROXIMATELY 9 MONTHS AGO DUE TO EXCESSIVE BOND STRENGTHS HE WAS EXPERIENCING, WHICH MAY HAVE LED TO THE FRACTURED ENAMEL. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    TOOTH FRACTURE WHILE DEBONDING CARRIERE MOTION APPLIANCE WHEN REMOVING THE CARRIERE FROM #11 TOOTH, THE MESIAL EDGE OF THE TOOTH FRACTURED OFF WITH THE CARRIERE. THE PATIENT IS SYMPTOM FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379406 CARRIERE MOTION CLASS II BRACKET, METAL, ORTHODONTIC EJF ORTHO ORGANIZERS, INC. 424-925CN 00190707023362

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention