BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE MOTION 3D COLORS CLASS II 25MM LEFT - SILVER

    MDR report key: 8009692 · Received October 26, 2018

    Report

    Report Number
    2081322-2018-00001
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 8, 2018
    Manufacturer
    ORTHO ORGANIZERS, INC
    Product Code
    EJF
    UDI-DI
    00190707023379
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE (INS 181A REV C) AND QUICK START GUIDE (999-329 REV A) BOTH SPECIFICALLY STATE IN STEP 4 OF REMOVAL PROCESS: TAKE ONE OF THE RECOMMENDED REMOVAL INSTRUMENTS AND PLACE THE TIP ENDS AT THE ADHESIVE INTERFACE (CONCAVE CHANNEL) BETWEEN THE MOTION 3D APPLIANCE CUSPID PAD AND THE TOOTH SURFACE. ORIENT THE INSTRUMENT TOWARD THE MESIAL ASPECT OF THE CUSPID OR BICUSPID PAD IN AN OCCLUSAL/GINGIVAL ASPECT. GENTLY SQUEEZE, APPLYING INCREASED CONTINUOUS PRESSURE, WITHOUT ANY TWISTING OR PULLING UNTIL THE BOND FAILS. IN THIS INSTANCE, THE DENTIST STATED THAT THE SIDES OF THE PAD OF THE DEVICE WAS USED. IN ADDITION, EXAMINATION OF THE RETURNED PRODUCT HAS EVIDENCE OF TOOL MARKS ON THE PRODUCT, NOT ON THE ADHESIVE INTERFACE.

    Description of Event or Problem · 1

    WHILE THE TECHNICIAN WAS REMOVING CARRIERE MOTION 3D COLORS CLASS II 25MM LEFT - SILVER, UPPER LEFT 3 CANINE FRACTURED. PER THE DENTIST, THE FOLLOWING STEPS WERE TAKEN: REMOVAL OF EXCESS ADHESIVE WITH HIGH SPEED HAND PIECE; HAVING PATIENT BITE ON COTTON ROLL; SQUEEZING ON EACH SIDE OF PAD WITH BRACKET REMOVING PLIER. DEVICE WAS BONDED ON (B)(6) 2018 AND WAS BEING DEBONDED DUE TO THE PATIENT BEING FINISHED WITH THE TREATMENT STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849932 CARRIERE MOTION 3D COLORS CLASS II 25MM LEFT - SILVER DISTALIZER EJF ORTHO ORGANIZERS, INC 424-925LN 00190707023379

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Disability TRANSBOND ADHESIVE - 3M UNITEK