BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS INC.

    MDR report key: 13270180 · Received January 17, 2022

    Report

    Report Number
    3012787974-2021-80045
    Event Type
    Injury
    Date Received
    January 17, 2022
    Date of Event
    December 17, 2021
    Report Date
    January 14, 2022
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K161399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 PLAN NOTED THAT THE IMPLANTS WERE PLANNED WITHIN 1MM OF EACH OTHER. WITH REVIEW OF AVAILABLE INFORMATION THERE ARE NO INDICATIONS OF A MALFUNCTION OF THE DEVICE OR FAILURE TO MEET SPECIFICATIONS. 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 SURGEON REMOVED THE IMPLANT AND REDRILLED THE OSTEOTOMY FREEHAND. NO INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 0

    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 PLAN NOTED THAT THE IMPLANTS WERE PLANNED WITHIN 1MM OF EACH OTHER. WITH REVIEW OF AVAILABLE INFORMATION THERE ARE NO INDICATIONS OF A MALFUNCTION OF THE DEVICE OR FAILURE TO MEET SPECIFICATIONS. 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 SURGEON REMOVED THE IMPLANT AND REDRILLED THE OSTEOTOMY FREEHAND. NO INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    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 IMPLANTS PLACED WERE TOO CLOSE AND WERE NOT AT THE DESIRED LOCATION. THE USER REMOVED ONE IMPLANT AND REDRILLED THE OSTEOTOMY FREEHAND. NO PERMANENT INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    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 IMPLANTS PLACED WERE TOO CLOSE AND WERE NOT AT THE DESIRED LOCATION. THE USER REMOVED ONE 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
    849417 NEOCIS INC. DENTAL STEREOTAXIC INSTRUMENT PLV NEOCIS INC. GEN 1 N/A 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention