BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 23103020 · Received September 19, 2025

    Report

    Report Number
    3012787974-2025-80096
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    May 7, 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
    NC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. THE IMPLANT FAILURE WAS REPORTED BY THE USER. LOGFILE ANALYSIS WAS PERFORMED AND THERE WAS NO INDICATION OF A LOSS OF ACCURACY OF THE DEVICE OR DEVICE ERROR THAT COULD HAVE RESULTED IN THE ISSUE NOTED. A DEFINITIVE ROOT CAUSE FOR THE IMPLANT FAILURE COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. PER LOGFILES, THE OSTEOTOMY WAS COMPLETED AND THE IMPLANT WAS PLACED WITH THE DEVICE TO A MAX DEPTH OF 12.48MM. POSSIBLE REASONS FOR IMPLANT FAILURE COULD BE ASSOCIATED WITH INSUFFICIENT BONE QUALITY, POOR ORAL HYGIENE, OVERHEATING THE BONE DURING THE DRILLING PROCESS, OR OTHER MEDICAL OR LIFESTYLE CHOICES (SMOKING OR OTHER HEALTH CONDITIONS). THE AREA WAS GRAFTED, AND THE IMPLANT WAS REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE IMPLANT FAILED AFTER ROBOTIC PLACEMENT. THE IMPLANT WAS REMOVED AND THE AREA WAS GRAFTED. THE PATIENT WAS SCHEDULED TO RETURN FOR A NEW IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228220 NEOCIS GUIDANCE SYSTEM YOMI PLV NEOCIS INC. DRW-1000-00 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention