BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBRACE

    MDR report key: 11899032 · Received May 27, 2021

    Report

    Report Number
    3013023655-2021-00003
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    June 27, 2019
    Report Date
    May 27, 2021
    Manufacturer
    SWIFT HEALTH SYSTEMS, INC
    Product Code
    DZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD HER FINAL WIRES PLACED A FEW WEEKS BEFORE THE ORTHODONTIST NOTICED THAT THE LOWER INTERDENTAL LOOP OF THE WIRE WAS DEEPLY EMBEDDED INTO THE GINGIVA. THE ISSUE WAS MOST LIKELY RELATED TO THE WIRE INTERDENTAL LOOPS BEING TOO CLOSE TO THE GINGIVA.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A LARGE AMOUNT OF WIRE DEEPLY EMBEDDED INTO THE LINGUAL GINGIVA BETWEEN THE LOWER LEFT 3-4 TOOTH. THE ORTHODONTIST TRIED TO RELEASE THE WIRE BY PULLING IT THROUGH THE GINGIVA, THEN WITH A SCALPEL BY MAKING SMALL INCISIONS. ULTIMATELY, THE WIRE WAS CUT AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794940 INBRACE ORTHODONTIC APPLIANCE DZC SWIFT HEALTH SYSTEMS, INC 8130

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention