BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 11829589 · Received May 14, 2021

    Report

    Report Number
    3012787974-2021-80012
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 14, 2021
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K202100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING NARRATIVE IS FOLLOW-UP INFORMATION TO AN MDR PREVIOUSLY SUBMITTED BY NEOCIS. FUNCTIONAL TESTING OF THE RETURNED NEOCIS SYSTEM WAS PERFORMED AND IT WAS NOTED THAT THE GUIDANCE ARM APPEARED TO HAVE A 0.5MM DEVIATION IN ACCURACY WHEN APPROACHED FROM OPPOSITE DIRECTIONS. LOGFILE ANALYSIS WAS PERFORMED AND THERE WAS NO INDICATION OF SYSTEM ERRORS DURING THE PROCEDURE. A DEFINITIVE ROOT CAUSE FOR THE LOSS OF ACCURACY NOTED COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES FOR THE LOSS OF ACCURACY NOTED COULD BE ATTRIBUTED TO A MOVEMENT OF THE SPLINT DURING THE PROCEDURE, IMPROPER HANDPIECE PLACEMENT OR ISSUES RELATED TO PLANNING. FIELD SERVICING WAS PERFORMED FOLLOWING THIS EVENT AND THE SYSTEM WAS REPLACED. THERE WAS NO INDICATION OF DAMAGE TO THE ANATOMY, THE IMPLANT WAS REMOVED AND REPLACED BY HAND. NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    COMPLETION OF THE INVESTIGATION TO DETERMINE ROOT CAUSE IS CURRENTLY PENDING. AN ADDITIONAL NARRATIVE WILL BE PROVIDED WITH A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE USER'S IMPLANT PLACEMENT WITH THE NEOCIS GUIDANCE SYSTEM (NGS), THE USER WAS NOT HAPPY WITH THE FINAL IMPLANT PLACEMENT. THE USER DECIDED TO REMOVE THE IMPLANT AND REPLACE IT BY HAND. NO FURTHER INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. AN INVESTIGATION TO DETERMINE ROOT CAUSE IS CURRENTLY IN PROCESS. THIS ISSUE IS BEING REPORTED IN ADVANCE OF COMPLETION OF THE INVESTIGATION IN AN ABUNDANCE OF CAUTION TO BE IN FULL COMPLIANCE WITH 21 PART 803 MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725654 NEOCIS GUIDANCE SYSTEM DENTAL STEREOTAXIC INSTRUMENT PLV NEOCIS INC. GEN 1 N/A 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention