BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR-VIZ MINI BRACKET

    MDR report key: 10240550 · Received July 7, 2020

    Report

    Report Number
    0001937100-2020-00001
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 19, 2020
    Report Date
    July 6, 2020
    Manufacturer
    DYNAFLEX
    Product Code
    NJM
    UDI-DI
    D841300XX18
    PMA / PMN Number
    K120471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE BRACKET CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. DYNAFLEX RELABELS AND REPACKAGES THE BRACKET WHICH IS ORIGINALLY MANUFACTURED BY (B)(4) UNDER THE NAME (B)(4). 510K IS HELD BY (B)(4). THIS IS AN ISOLATED INCIDENT AND DYNAFLEX HAS NOT RECEIVED ANY OTHER COMPLAINTS ABOUT TOOTH BREAKAGE ASSOCIATED WITH THIS PRODUCT IN THE MANY YEARS OF SALES.

    Description of Event or Problem · 1

    WHILE ORTHODONTIST WAS REMOVING THE BRACKET FROM TOOTH #8, THE PATIENT'S TOOTH CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705335 CLEAR-VIZ MINI BRACKET CERAMIC BRACKET NJM DYNAFLEX 300-R2(XX) 1965 D841300XX18

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention