BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE SLX

    MDR report key: 6437596 · Received March 27, 2017

    Report

    Report Number
    2081322-2017-00001
    Event Type
    Injury
    Date Received
    March 27, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 1, 2017
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRACKET WAS REMOVED BY THE DENTAL HYGIENIST DURING ORTHODONTIC TREATMENT TO REPOSITION THE BRACKET TO BE IN A BETTER POSITION FOR ADDITIONAL ALIGNMENT. THIS IS THE FIRST REPORT OF THIS NATURE WITH THE CARRIERE SLX BRACKET.

    Description of Event or Problem · 1

    WHILE REMOVING AN ORTHODONTIC BRACKET FROM THE LOWER RIGHT CENTRAL INCISOR, THE TOOTH FRACTURED IN HALF THROUGH THE PULP CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219591 CARRIERE SLX ORTHODONTIC METAL BRACKET EJF ORTHO ORGANIZERS, INC. 713-335-10

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention 3M UNITEK TRANS BOND