BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS INC.

    MDR report key: 13458460 · Received February 4, 2022

    Report

    Report Number
    3012787974-2022-80046
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    January 7, 2022
    Report Date
    February 4, 2022
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K161399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE USING THE NEOCIS GUIDANCE SYSTEM (NGS) DURING IMPLANT PLACEMENT THE USER ATTEMPTED TO PUT THE GUIDANCE ARM INTO AN ORIENTATION THAT COULD NOT BE ACHIEVED BY THE ARM. THE USER ADJUSTED THE APPROACH MULTIPLE TIMES YET ENDED UP ATTEMPTING TO PLACE THE ARM IN THE SAME UNREACHABLE ORIENTATION. THE SYSTEM ENTERED PAUSE MODE, RECORDED HIGH FORCES AND THE GUIDANCE ARM SHUTDOWN. THE USER THEN ATTEMPTED TO REMOVE THE HANDPIECE FROM THE SYSTEM, YET HE WAS UNABLE TO REMOVE THE PART. THE USER PROCEEDED TO USE THE DRILL SYSTEM TO REMOVE THE HANDPIECE FROM THE PATIENT'S MOUTH WHEN THE PATIENT MOVED UNEXPECTEDLY AND THE DRILL BIT CONTACTED THE PATIENT'S JAW TISSUE CAUSING A LACERATION. THE SYSTEM WAS PAUSED AND MOVED AWAY FROM THE PATIENT, THE USER PLACED SUTURES AT THE CONTACT SITE. NO FURTHER PATIENT COMPLICATIONS OR DEVICE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683437 NEOCIS INC. DENTAL STEREOTAXIC INSTRUMENT PLV NEOCIS INC. GEN 1 N/A 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention