BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE MOTION CLASS II

    MDR report key: 5806669 · Received July 19, 2016

    Report

    Report Number
    2081322-2016-00001
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    June 6, 2016
    Report Date
    June 22, 2016
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER CORRECTED FROM 794305 TO 794306.

    Additional Manufacturer Narrative · 1

    TOOTH FRACTURE CAN OCCUR UPON DEBONDING (REMOVAL) OF DEVICE. LITERATURE DESCRIBING DEBONDING ADVERSE EVENTS CAN BE TRACED BACK TO AT LEAST 1996. THIS WAS A NEW USER OF THE DEVICE. LITERATURE ACCOMPANYING DEVICE SPECIFICALLY STATES THE INSTRUMENTS TO USE, AND THAT DEBONDING IS CONDUCTED WITHOUT TWISTING OR PULLING. PROVIDERS ARE TRAINED TO USE CARE WHEN DEBONDING DEVICE. PROVIDER RE-TRAINED ON DEBONDING PROTOCOL AND PROVIDED WITH APPROPRIATE INSTRUMENTS TO USE FOR DEBONDING.

    Description of Event or Problem · 1

    PATIENT WAS IN TO HAVE DEVICE REMOVED AFTER 4 MONTHS OF USE. PROVIDER REMOVED EXCESS ADHESIVE FROM AROUND DEVICE. WITH A PAIR OF 'REGULAR' PLIERS, APPLIED TWISTING MOTION TO DEFORM AND DEBOND THE DEVICE. DEVICE DEBONDED FROM SURFACE AND PATCH OF ENAMEL BROKE OFF AND REMAINED ATTACHED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460737 CARRIERE MOTION CLASS II CARRIERE MOTION CLASS II EJF ORTHO ORGANIZERS, INC. 424-925LN 794306

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention