BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 20025521 · Received August 22, 2024

    Report

    Report Number
    3012787974-2024-80088
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 22, 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
    MA, 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

    AFTER GUIDED PROCEDURE FOR AN EDENTULOUS REGION WITH A NARROW RIDGE, IT WAS FOUND THAT THE IMPLANT PENETRATED THE BUCCAL PLATE. THE USER REMOVED THE IMPLANT AND PLACED IT AT A SEPARATE LOCATION BY HAND. A REVIEW OF THE YOMI SYSTEM'S LOG FILES DID NOT INDICATE ANY SYSTEM MALFUNCTION. PER REVIEW OF PATIENT SCANS, THE IMPLANT WAS PLANNED AT CLOSE PROXIMITY OF THE BUCCAL PLATE. FURTHER REVIEW WITH THE CUSTOMER INDICATED THAT THE PATIENT'S BONE QUALITY AT THE PLANNED LOCATION MAY HAVE AFFECTED THE EVENT. NO FURTHER INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273515 NEOCIS GUIDANCE SYSTEM DENTAL NAVIGATION SYSTEM PLV NEOCIS INC. DRW-1000-00 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention