BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 19101243 · Received April 12, 2024

    Report

    Report Number
    3012787974-2024-80086
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 23, 2025
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K161399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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

    TWO DAYS AFTER GUIDED PROCEDURE THE PATIENT RETURNED TO THE SURGEON OFFICE COMPLAINING OF PAIN. A POST-OPERATIVE SCAN REVIEW SHOWED THE IMPLANT 2MM OUTSIDE OF THE PLANNED PATH. A POST-OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED AND A SYSTEM ACCURACY CHECK WAS COMPLETED. THE LIKELY ROOT CAUSE FOR THE ISSUE WAS ATTRIBUTED TO SKYVING OF THE DRILL BIT. THE SURGEON REMOVED THE IMPLANT, RECONTOURED THE BONE AND REPLACED IT. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS ISSUE. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509188 NEOCIS GUIDANCE SYSTEM DENTAL NAVIGATION SYSTEM PLV NEOCIS INC. DRW-1000-00 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention