BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC CLARITY METAL-REINFORCED CERAMIC BRACKET

    MDR report key: 337571 · Received June 15, 2001

    Report

    Report Number
    2020467-2001-00004
    Event Type
    Injury
    Date Received
    June 15, 2001
    Date of Event
    April 26, 2001
    Report Date
    May 21, 2001
    Manufacturer
    3M UNITEK
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 AN ENAMEL FRAGMENT MEASURING APPROXIMATELY 1MM X 2MM AND 1.5MM IN DEPTH WAS REMOVED FROM THE BUCCAL SURFACE OF AN UPPER RIGHT SECOND BICUSPID TOOTH. ORTHODONTIST REPAIRED THE TOOTH WITH COMPOSITE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27421 APC CLARITY METAL-REINFORCED CERAMIC BRACKET ORTHODONTIC CERAMIC BRACKET EJF 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention PRIMER UNITEK DEBRACKETING INSTRUMENT.| ORTHODONTIC BANDS, BUCCAL TUBES, ARCHWIRES,| THERAPY DATES: 2000 THRU 2001.