BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE MOTION CLASS II

    MDR report key: 6599793 · Received May 30, 2017

    Report

    Report Number
    2081322-2017-00003
    Event Type
    Injury
    Date Received
    May 30, 2017
    Date of Event
    January 1, 2016
    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 FROM AROUND UL3 AND UL6 AND USED A BRACKET REMOVING PLIER TO SQUEEZE BETWEEN THE PAD AND TOOTH. A 1MM DIVOT OF ENAMEL WAS MISSING FROM THE BUCCAL SURFACE OF TOOTH UL6. THE ORTHODONTIST BONDED A SMALL AMOUNT OF FLOWABLE COMPOSITE TO THE FRACTURED ENAMEL. HE SWITCHED 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

    WHEN REMOVING THE CARRIERE MOTION APPLIANCE FROM TOOTH NUMBER 14, A SMALL FRACTURE OF ENAMEL BROKE OFF WITH THE APPLIANCE LOCATED ON THE BUCCAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379515 CARRIERE MOTION CLASS II BRACKET, METAL, ORTHODONTIC EJF ORTHO ORGANIZERS, INC 424-925CN 00190707023362

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention