BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YOMI ROBOTIC SYSTEM

    MDR report key: 18127880 · Received November 13, 2023

    Report

    Report Number
    3012787974-2023-80079
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 13, 2023
    Manufacturer
    NEOCIS, INC.
    Product Code
    QRY
    UDI-DI
    00810004900004
    PMA / PMN Number
    K222750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 PARTIALLY COMPROMISED THE BUCCAL WALL. A POST OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED. A SLIGHT HANDPIECE ROTATION WAS DETERMINED TO BE THE LIKELY ROOT CAUSE OF THE EVENT AS IT WOULD EXPLAIN THE 1.0 MM ERROR DURING THE LANDMARK CHECK AND ALSO WHY PART OF THE IMPLANT WAS OUTSIDE THE BUCCAL WALL. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT. THERE WERE NO FURTHER ISSUES NOTED WITH THE REPLACED IMPLANT AS WELL AS THE 2ND IMPLANT PLACEMENT. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS. 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
    2203334 YOMI ROBOTIC SYSTEM DENTAL NAVIGATION SYSTEM QRY NEOCIS, INC. GEN 1 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention