BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC PLUS SMARTCLIP MBT

    MDR report key: 1639197 · Received March 23, 2010

    Report

    Report Number
    2020467-2010-00001
    Event Type
    Injury
    Date Received
    March 23, 2010
    Report Date
    February 24, 2010
    Manufacturer
    3M UNITEK
    Product Code
    EJF
    PMA / PMN Number
    K020394
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG#: 5004-348.

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT ENAMEL DOWN-TO-DENTIN ON A LOWER SECOND PREMOLAR WAS REMOVED WHEN THE BRACKET WAS DEBONDED. ORTHODONTIST REPAIRED PT'S TOOTH WITH COMPOSITE. ORTHODONTIST DECLINED TO PROVIDE ANY ADD'L INFO ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APC PLUS SMARTCLIP MBT ORTHODONTIC METAL BRACKET EJF 3M UNITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention