BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBRACE TOOTH STRAIGHTENING SYSTEM (GEN 2.0)

    MDR report key: 16261770 · Received January 29, 2023

    Report

    Report Number
    3023370823-2023-00001
    Event Type
    Injury
    Date Received
    January 29, 2023
    Date of Event
    January 5, 2023
    Report Date
    January 29, 2023
    Manufacturer
    SWIFT HEALTH SYSTEMS, INC.
    Product Code
    DZC
    PMA / PMN Number
    K203442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD HER SMARTWIRES PLACED A FEW WEEKS BEFORE THE ORTHODONTIST NOTICED THAT THE GINGIVAL PAPILLA GOT INFLAMED CAUSING SWELLING AND COVERING OF THE UPPER SMARTWIRE INTERPROXIMAL LOOP BETWEEN THE UPPER CENTRAL INCISORS. ACCORDING TO THE ORTHODONTIST, THIS TYPE OF INFLAMMATION IS FREQUENTLY SEEN IN ORTHODONTIC PATIENTS WHO DO NOT PRACTICE GOOD ORAL HYGIENE SUCH AS REGULAR FLOSSING AND BUSHING. PROPER ORAL HYGIENE INSTRUCTIONS WERE PROVIDED TO THE PATIENT INCLUDING MANUAL AND WATER FLOSSING.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED TISSUE INFLAMMATION AND AN INTERPROXIMAL LOOP OF THE UPPER SMARTWIRE EMBEDDED IN THE GINGIVAL PAPILLA BETWEEN THE UPPER CENTRAL INCISORS. THE SMARTWIRE WAS SECTIONED AND REMOVED TO ALLOW THE PAPILLA TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977848 INBRACE TOOTH STRAIGHTENING SYSTEM (GEN 2.0) ORTHODONTIC APPLIANCE DZC SWIFT HEALTH SYSTEMS, INC. 85004

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention