BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC II CLARITY METAL-REINFORCED CERAMIC BRACKET

    MDR report key: 545463 · Received September 22, 2004

    Report

    Report Number
    2020467-2004-00009
    Event Type
    Injury
    Date Received
    September 22, 2004
    Date of Event
    August 31, 2004
    Report Date
    September 13, 2004
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT A PIECE OF ENAMEL DOWN-TO-DENTIN WAS REMOVED FROM PT'S RIGHT CENTRAL INCISOR TOOTH WHEN THE BRACKET SPONTANEOUSLY DEBONDED. PT THINKS THE BRACKET MAY HAVE DEBONDED WHILE EATING. ORTHODONTIST STATED THAT PT'S TOOTH WILL BE REPAIRED WITH A VENEER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention & ARCHWIRES. THERAPY DATE: 2004 TO PRESENT.| TRANSBOND PLUS SELF ETCHING PRIMER METAL BRACKETS