BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 17346955 · Received July 18, 2023

    Report

    Report Number
    3012787974-2023-80072
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 19, 2023
    Report Date
    April 23, 2025
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K161399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G3.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. UPDATES BASED ON UDI/MDR DATA QUALITY NOTIFICATION RECEIVED ON DECEMBER 13, 2024.

    Description of Event or Problem · 0

    DURING A GUIDED IMPLANT PLACEMENT, THE IMPLANT WAS PLACED TOO BUCAL WHEN COMPARED TO PLAN. THE SURGEON REMOVED THE IMPLANT AND GRAFTED THE SITE. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766715 NEOCIS GUIDANCE SYSTEM DENTAL NAVIGATION SYSTEM PLV NEOCIS INC. DRW-1000-00 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other