BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 23094726 · Received September 19, 2025

    Report

    Report Number
    3012787974-2025-80097
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    April 23, 2025
    Report Date
    September 19, 2025
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K161399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. THE ADVERSE EVENT WAS RELATED TO THE PATIENT'S CONDITION AND REACTION TO ANESTHESIA, NOT THE USE OF THE DEVICE. WITH REVIEW OF AVAILABLE INFORMATION, THERE ARE NO INDICATIONS OF A MALFUNCTION OF THE DEVICE OR FAILURE TO MEET SPECIFICATIONS. THE USER SELECTED TO REMOVE THE YOMILINK BONE DURING THE EMERGENCY. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND STABILIZED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE ROBOTIC PROCEDURE AND FOLLOWING ADMINISTRATION OF ANESTHESIA, THE PATIENT'S HEART RATE DROPPED. THE USER REMOVED THE YOMILINK BONE QUICKLY AND CALLED EMERGENCY SERVICES. THE PATIENT WAS TAKEN TO THE HOSPITAL AND STABILIZED. NO FURTHER INJURIES OR MEDICAL INTERVENTION WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759763 NEOCIS GUIDANCE SYSTEM YOMI PLV NEOCIS INC. DRW-1000-00 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O