BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTFORCE ORTHODONTIC SYSTEM

    MDR report key: 19259204 · Received May 7, 2024

    Report

    Report Number
    3013770639-2024-00001
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    December 15, 2023
    Report Date
    February 2, 2024
    Manufacturer
    LIGHTFORCE ORTHODONTICS
    Product Code
    NJM
    UDI-DI
    00860270000953
    PMA / PMN Number
    K222764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LIGHTFORCE ORTHODONTIC SYSTEM INSTRUCTIONS FOR USE CONTAIN THE PRECAUTION "INSTRUCT NO TO CHEW OR BITE HARD SUBSTANCES SUCH AS HARD CANDY, ICE, OR CARROTS. CAREFUL AND THOROUGH PATIENT INSTRUCTION IS KEY TO AVOIDING APPLIANCE OR ENAMEL DAMAGE". AN INTERNAL LOT RECORD REVIEW WAS ALSO CONDUCTED, AND THE RESULTS INDICATE THIS LOT WAS PROCESSED WITHOUT INCIDENT. THE ROOT CAUSE INVESTIGATION CONCLUSION FOR THIS ADVERSE EVENT IS THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS FDA CODE 18. THIS IS THE FIRST ELECTRONIC MDR SUBMITTTED BY THE COMPNAY AND THE REPORT WAS DELAYED DUE TO THE ESG / WEB TRADER SIGNUP PROCESS.

    Description of Event or Problem · 0

    LIGHTFORCE ORTHODONTICS WAS NOTIFIED THAT THE ORTHODONTIST REMOVED A SINGE MOLAR TUBE (LR6) BRACKET FROM THE LIGTHFORCE ORTHODONTIC SYSTEM AND A PIECE OF ENAMEL FROM THE TOOTH CAME OFF WITH THE BRACKET. AFTER FURTHER DISCUSSION WITH THE ORTHODONTIST, IT WAS CONFIRMED THAT THE PATIENT BIT DOWN ON A SPORTS MOUTHGUARD WHICH RESULTED IN THE BRACKET COMING OFF AND DENTIN BEING EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439476 LIGHTFORCE ORTHODONTIC SYSTEM ORTHODONTIC BRACKET NJM LIGHTFORCE ORTHODONTICS MFG-962308 00860270000953

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Other