BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE MOTION 3D COLORS CLASS II 22MM LEFT-SILVER

    MDR report key: 8204894 · Received December 28, 2018

    Report

    Report Number
    2081322-2018-00003
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    December 11, 2018
    Report Date
    December 17, 2018
    Manufacturer
    ORTHO ORGANIZERS, INC
    Product Code
    EJF
    UDI-DI
    00190707023287
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS BONDED ON (B)(6) 2018. INSTRUCTIONS FOR DEBONDING THE DEVICE STATE THAT THE PROTOCOL IS TO "ORIENT THE INSTRUMENT TOWARD THE MESIAL ASPECT OF THE CUSPID OR BICUSPID PAD IN AN OCCLUSAL/GINGIVAL ASPECT. GENTLY SQUEEZE, APPLYING INCREASED CONINUOUS PRESSURE, WITHOUT ANY TWISTING OR PULLING UNTIL THE BOND FAILS." BASED ON THE INPUT FROM THE ORTHODONTIST'S OFFICE, THE DEVICE WAS REMOVED USING THE PROTOCOL FOR REMOVING A BRACKET, WHICH LIKELY WOULD HAVE INCLUDED TWISTING AND PULLING MOTIONS.

    Description of Event or Problem · 1

    WHILE DENTAL HYGIENIST WAS DEBONDING ORTHODONTIC DEVICE, PATIENT EXPERIENCED AN ENAMEL FRACTURE OF UPPER LEFT CUSPID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043583 CARRIERE MOTION 3D COLORS CLASS II 22MM LEFT-SILVER METAL ORTHODONTIC BRACKET EJF ORTHO ORGANIZERS, INC 424-922LN 00190707023287

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention