BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOGNITO(TM)

    MDR report key: 5446874 · Received February 19, 2016

    Report

    Report Number
    2020467-2016-00001
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    January 20, 2016
    Report Date
    February 18, 2016
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS DESCRIBED BY ORTHODONTIST AS HAVING A TIGHT BITE AND THERE IS NO DOUBT HE CLENCHES HIS TEETH. THE LINGUAL BRACKETS WERE DEBONDED ON (B)(6) 2016 AND PATIENT IS CONTINUING TREATMENT WITH A REMOVABLE ORTHODONTIC APPLIANCE.

    Description of Event or Problem · 1

    ADULT MALE IN ORTHODONTIC TREATMENT USING LINGUAL BRACKETS, ORTHODONTIST REPORTED A BROKEN TOOTH, THE UPPER RIGHT 1ST BICUSPID. THERE WAS A CROWN ON THIS TOOTH. THE LINGUAL CUSP HAD SHEARED OFF, THE BUCCAL PORTION WAS LEFT INTACT. WHEN THE PATIENT FINISHES ORTHODONTIC TREATMENT, THIS TOOTH WILL BE EXTRACTED AND REPLACED WITH AN IMPLANT. IN SPEAKING WITH THE DOCTOR, SHE MENTIONED A PRIOR TOOTH BREAKAGE, THE UPPER LEFT 2ND MOLAR. THIS TOOTH ALSO HAD A CROWN. THE TOOTH BROKE OFF AT THE GUMLINE AND WAS EXTRACTED BY AN ORAL SURGEON IN (B)(6) 2015. THIS WAS NOT REPORTED TO THE MANUFACTURER AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104999 INCOGNITO(TM) BRACKET, METAL, ORTHODONTIC EJF 3M UNITEK CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention