BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 18070782 · Received November 5, 2023

    Report

    Report Number
    3012787974-2023-80075
    Event Type
    Malfunction
    Date Received
    November 5, 2023
    Date of Event
    September 8, 2023
    Report Date
    December 24, 2024
    Manufacturer
    NEOCIS, INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K161399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 13TH DEC 2024.

    Description of Event or Problem · 0

    AFTER A GUIDED PROCEDURE AND POST-OPERATIVE ASSESSMENT, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. THE SURGEON REMOVED THE IMPLANT AND RELOCATED IT IN A FREEHAND MANNER. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953167 NEOCIS GUIDANCE SYSTEM DENTAL NAVIGATION SYSTEM PLV NEOCIS, INC. DRW-1000-00 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention