BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YOMI ROBOTIC SYSTEM

    MDR report key: 18070925 · Received November 6, 2023

    Report

    Report Number
    3012787974-2023-80078
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 5, 2023
    Manufacturer
    NEOCIS, INC.
    Product Code
    QRY
    UDI-DI
    00810004900004
    PMA / PMN Number
    K222750
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G3.

    Description of Event or Problem · 0

    AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT 1 OF 2 IMPLANT PLACEMENTS WERE NOT ACCORDING TO THE SURGICAL PLAN. ONE IMPLANT WAS PLACED BUCCAL TO PLAN. AN ANALYSIS OF THE SYSTEM LOG FILES AND A POST-OP CT SCAN WAS COMPLETED. SOME CONTRIBUTING FACTORS WERE IDENTIFIED I.E., PATIENT WAS OUTSIDE OF THE RECOMMENDED WORK VOLUME, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A QUICK CHECK OF THE SYSTEM WAS ALSO PERFORMED AFTER THE PROCEDURE AND THE SYSTEM WAS FOUND TO BE IN GOOD WORKING ORDER. SUCCESSFUL PROCEDURES HAVE BEEN PERFORMED SINCE THIS EVENT HOWEVER FIELD SERVICE WILL STILL BE CONTACTED TO DETERMINE IF SERVICING OF THE SYSTEM IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154705 YOMI ROBOTIC SYSTEM DENTAL NAVIGATION SYSTEM QRY NEOCIS, INC. GEN 1 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention