BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBRACE TEETH STRAIGTHENING SYSTEM ( GEN 2.0)

    MDR report key: 15756633 · Received November 8, 2022

    Report

    Report Number
    3013023655-2022-00002
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    November 1, 2022
    Report Date
    November 7, 2022
    Manufacturer
    SWIFT HEALTH SYSTEMS, INC.
    Product Code
    DZC
    UDI-DI
    00850018135047
    PMA / PMN Number
    K203442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD HER INITIAL WIRES PLACED A FEW MONTHS BEFORE THE ORTHODONTIST NOTICED THAT THE UPPER WIRE WAS EMBEDDED INTO THE ANTERIOR GINGIVA. NO PROGRESS RECORDS WERE PROVIDED TO DETERMINE IF THE ISSUE WAS AN ORAL HYGIENE PROBLEM. NO WIRE DEFECT WAS IDENTIFED.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED AN ORTHODONTIC WIRE EMBEDDED INTO THE LINGUAL GINGIVA, BETWEEN THE UPPER ANTERIOR TOOTH # 8 AND # 9. THE WIRE WAS CUT INTO SECTIONS AND EACH SECTION REMOVED BY PULLING THROUGH THE GINGIVA.. THE PATIENT WAS INSTRUCTED TO RINSE THE MOUTH WITH WARM SALT WATER AND ALOW 4-5 WEEKS TO HEAL THE TISSUE PRIOR TO INSERTION OF A NEW WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2688884 INBRACE TEETH STRAIGTHENING SYSTEM ( GEN 2.0) ORTHODONTIC APPLIANCE DZC SWIFT HEALTH SYSTEMS, INC. 85000 00850018135047

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention