BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS INC.

    MDR report key: 12747839 · Received November 3, 2021

    Report

    Report Number
    3012787974-2021-80016
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    August 12, 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
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRACKER END EFFECTOR ASSOCIATED WITH THE SYSTEM WAS RETURNED. A REVIEW OF THE SYSTEM'S LOGFILE WAS PERFORMED AND IT WAS NOTED THAT THE LANDMARK ACCURACY CHECK PASSED. REVIEW OF LOGFILES DID NOT FIND ANY SYSTEM ERRORS THAT COULD HAVE RESULTED IN THE LOSS OF ACCURACY NOTED. FIELD SERVICING WAS PERFORMED FOLLOWING THE ISSUE REPORTED AND THE TRACKER END EFFECTOR WAS NOTED TO HAVE DIFFICULTY SECURING WITH THE TRACKER, AS A RESULT THE TRACKED END EFFECTOR WAS RETURNED. A REVIEW OF THE RETURNED TRACKER END EFFECTOR DID NOT FIND ANY ISSUES THAT COULD HAVE RESULTED IN THE ISSUE NOTED, THE TRACKER END EFFECTOR WAS CONFIRMED TO WORK AS EXPECTED. PER REVIEW OF EVENT WITH NEOCIS REPRESENTATIVE ON SITE IT WAS NOTED THAT THE PLACEMENT OF THE SPLINT RESULTED IN LIMITED VISIBILITY FOR THE USER. A DEFINITIVE ROOT CAUSE FOR THE LOSS OF ACCURACY NOTED ON ONE IMPLANT COULD NOT BE DETERMINED. POSSIBLE FACTORS THAT MAY HAVE CONTRIBUTED TO THIS ISSUE COULD BE THE PATIENT'S ANATOMY AND OTHER PROCEDURAL FACTORS (EX. PLANNING RELATED FACTORS OR SPLINT LOCATION SELECTION). THE IMPLANT WAS REMOVED BY THE USER AND REPLACED FREEHAND. FIELD SERVICING WAS PERFORMED FOLLOWING THIS ISSUE AND THE SYSTEM WAS CONFIRMED TO MEET SPECIFICATIONS FOR ACCURACY. 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. A GRAFT WAS PLACED ON THE INITIAL OSTEOTOMY PERFORMED. NO INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646707 NEOCIS INC. DENTAL STEREOTAXIC INSTRUMENT PLV GEN 1 N/A 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention