BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS INC.

    MDR report key: 12747937 · Received November 3, 2021

    Report

    Report Number
    3012787974-2021-80017
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    September 21, 2021
    Report Date
    November 3, 2021
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K161399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. A REVIEW OF THE SYSTEM'S LOGFILE WAS PERFORMED AND IT WAS NOTED THAT THE LANDMARK ACCURACY CHECK PASSED, NO SYSTEM ERRORS WERE FOUND, AND BASED ON THE LOGFILE REVIEW THE SYSTEM WAS WITHIN ACCURACY SPECIFICATION. REVIEW OF IMPLANT PLACEMENT NOTED THAT THE IMPLANT APPEARED TO BE AT THE EXPECTED LOCATION PER THE PLAN. POSSIBLE ROOT CAUSES OF THIS EVENT INCLUDE FACTORS RELATED TO THE SURGEON'S PLANNING, PATIENT-SPECIFIC HEALTH ISSUES, AND THE SURGEON'S OVERALL CLINICAL TECHNIQUE. THE USER REMOVED THE IMPLANT AND PLACED A NEW IMPLANT AT AN ADJACENT LOCATION. NO INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. ISSUES OF THIS NATURE WILL BE TRACKED AND TRENDED TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY. ALSO, DUE TO PERSONNEL CHANGES AT NEOCIS, RE-REGISTRATION FOR FILING EMDRS THROUGH FDA ESG WAS DELAYED CAUSING THIS MDR TO BE SUBMITTED PAST DUE FROM THE REQUIRED 30 DAY FILING PERIOD. RE-REGISTRATION WAS SUCCESSFULLY COMPLETED RECENTLY SO THERE SHOULD BE NO FURTHER FILING ISSUES GOING FORWARD.

    Description of Event or Problem · 1

    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. THE USER REMOVED THE IMPLANT AND PLACED A NEW IMPLANT AT AN ADJACENT LOCATION. 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
    1643654 NEOCIS INC. DENTAL STEREOTAXIC INSTRUMENT PLV GEN 1 N/A 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention