BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBRACE TEETH STRAIGHTENING SYSTEM

    MDR report key: 16406097 · Received February 20, 2023

    Report

    Report Number
    3023370823-2023-00002
    Event Type
    Injury
    Date Received
    February 20, 2023
    Date of Event
    February 10, 2023
    Report Date
    February 20, 2023
    Manufacturer
    SWIFT HEALTH SYSTEMS. INC.
    Product Code
    DZC
    UDI-DI
    00850018135122
    PMA / PMN Number
    K203442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT EXPERIENCED A PALATAL SWELLING BETWEEN THE UPPER FRONT TEETH WHILE WEARING INBRACE APPLIANCE SYSTEM. THE UPPER SMARTWIRE WAS CUT, REMOVED AND REPLACED TO FINISH THE TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S UPPER SMARTWIRE WAS CUT IN HALF DUE A PALATAL SWELLING BETWEEN THE UPPER FRONT TEETH. THE SMARTWIRE WAS PUSHING ON THE PALATE AND HAD TO BE REMOVED. THE ORTHODONTIST REMOVED THE WIRE AND REQUESTED A WIRE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644074 INBRACE TEETH STRAIGHTENING SYSTEM ORTHODONTIC APPLIANCE DZC SWIFT HEALTH SYSTEMS. INC. 8131 00850018135122

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention