BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 15085773 · Received July 22, 2022

    Report

    Report Number
    3012787974-2022-80047
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 24, 2022
    Report Date
    July 22, 2022
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K210711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. LOGFILE ANALYSIS WAS PERFORMED AND THE SYSTEM WAS CONFIRMED TO PASS INITIAL ANATOMICAL CHECK. SERVICING WAS PERFORMED AT THE CUSTOMER SITE AND IT WAS NOTED THAT THE SYSTEM APPEARED TO BE OUTSIDE OF CALIBRATED PARAMETERS. FIELD SERVICING WAS PERFORMED AND THE SYSTEM WAS RECALIBRATED TO RETURN TO EXPECTED FUNCTION. A POSSIBLE ROOT CAUSE FOR THE ISSUE NOTED COULD BE ATTRIBUTED TO A LOSS OF CALIBRATION OF THE SYSTEM. A DEFINITIVE ROOT CAUSE FOR THE LOSS OF CALIBRATION COULD NOT BE DETERMINED,MAY BE ASSOCIATED WITH MAINTENANCE OR HANDLING OF THE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DENTAL IMPLANT PROCEDURE WITH THE NEOCIS GUIDANCE SYSTEM (NGS) THE USER NOTED THAT THE IMPLANT WAS NOT AT THE DESIRED LOCATION AND WAS PLACED OUTSIDE OF THE PATIENT'S RIDGE. THE USER REMOVED THE IMPLANT AND REDRILLED THE OSTEOTOMY FREEHAND. NO PERMANENT INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560744 NEOCIS GUIDANCE SYSTEM DENTAL STEREOTAXIC INSTRUMENT PLV NEOCIS INC. GEN 1 N/A 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention