BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YOMI ROBOTIC SYSTEM

    MDR report key: 18070841 · Received November 5, 2023

    Report

    Report Number
    3012787974-2023-80077
    Event Type
    Injury
    Date Received
    November 5, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 5, 2023
    Manufacturer
    NEOCIS, INC.
    Product Code
    QRY
    UDI-DI
    00810004900004
    PMA / PMN Number
    K222750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. BASED ON AN ANALYSIS OF THE SYSTEM LOG FILES, IT WAS FOUND THAT THE SYSTEM WAS USED OFF LABEL. SPECIFICALLY, THE SPLINT USED REQUIRES A MINIMUM OF 3 BONE SCREWS TO ENSURE ACCURATE TRACKING OF PATIENT MOVEMENT, HOWEVER THE SURGEON USED ONLY 2 BONE SCREWS. ALTHOUGH THE SPLINT SEEMED STABLE DURING THE PROCEDURE PER FEEDBACK FROM THE FIELD, LIKELY ROOT CAUSE OF THIS EVENT IS SPLINT MOVEMENT DUE TO NOT USING THE REQUIRED MINIMUM OF 3 BONE SCREWS. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139842 YOMI ROBOTIC SYSTEM DENTAL NAVIGATION SYSTEM QRY NEOCIS, INC. GEN 1 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention