BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC CLARITY METAL-REINFORCED CERAMIC BRACKET

    MDR report key: 376060 · Received February 8, 2002

    Report

    Report Number
    2020467-2002-00001
    Event Type
    Injury
    Date Received
    February 8, 2002
    Date of Event
    January 16, 2002
    Report Date
    January 16, 2002
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT DURING THE DEBONDING OF AN "APC" CLARITY CERAMIC BRACKET, TOOTH DENTIN WAS EXPOSED WHEN A PIECE OF ENAMEL WAS REMOVED FROM A PATIENT'S LOWER RIGHT CUSPID TOOTH. ORTHODONTIST STATED THAT HE DID NOT USE EITHER OF THE DEBONDING INSTRUMENTS WHICH ARE LISTED IN THE INSTRUCTIONS-FOR-USE. TOOTH DENTIN WAS EXPOSED ON THE PATIENT'S LOWER LEFT CUSPID TOOTH WHEN PATIENT'S DENTIST USED A HISH SPEED DIAMOND BURR TO REMOVE A REMNANT CERAMIC ON THE TOOTH. BOTH TEETH WERE REPAIRED WITH COMPOSIT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APC CLARITY METAL-REINFORCED CERAMIC BRACKET ORTHODONTIC CERAMIC BRACKET DYW 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention THERAPY DATES: 2001-2002.| ORTHODONTIC ARCHWIRES, PRIMER, BANDS, BUCCAL TUBES| INSTRUMENTS, (ORTHODONTIC PLIERS AND CUTTERS)