BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 11829586 · Received May 14, 2021

    Report

    Report Number
    3012787974-2021-80011
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 14, 2021
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K202100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. WITH REVIEW OF AVAILABLE INFORMATION THERE ARE NO INDICATIONS OF A MALFUNCTION OF THE DEVICE OR FAILURE TO MEET SPECIFICATIONS. PER THE PHYSICIAN, THE APNEA DID NOT OCCUR AS A RESULT OF THE USE OF THE NGS. THE EVENT COULD BE RELATED TO ADMINISTRATION OF ANESTHESIA AND PATIENT MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING ADMINISTRATION OF IV SEDATION DURING A DENTAL IMPLANT PROCEDURE WITH THE NEOCIS GUIDANCE SYSTEM (NGS), THE PATIENT BECAME APNEIC. THE USER ATTEMPTED TO PLACE A BITE-BLOCK WITHOUT REMOVAL OF THE SPLINT WHICH RESULTED IN A SLIGHT DELAY. THE SPLINT WAS EASILY REMOVED, THE BITE BLOCK WAS SUCCESSFULLY PLACED, AND THE PATIENT'S BREATHING WAS RESTORED. NO INJURIES, DEVICE MALFUNCTIONS, OR INTERVENTIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722070 NEOCIS GUIDANCE SYSTEM DENTAL STEREOTAXIC INSTRUMENT PLV NEOCIS INC. GEN 1 N/A 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention