BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 9030243 · Received September 13, 2019

    Report

    Report Number
    3012787974-2019-80002
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 15, 2019
    Report Date
    August 20, 2019
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K182776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHAIRSIDE PATIENT SPLINT (CPS) IS USED TO CREATED A RIGID LINKAGE BETWEEN THE PATIENT AND THE ROBOTIC DEVICE. THE CPS IS AFFIXED TO THE PATIENT'S STABLE TEETH USING DENTAL MATERIALS SPECIFIED IN OUR LABELING. THERE IS A RISK THAT WHEN THE CPS IS REMOVED, DENTAL MATERIAL MAY REMAIN ON THE TEETH. OUR USER MANUAL (LB-0196) STATES, "REMOVE ANY REMAINING DENTAL MATERIAL USING STANDARD DENTAL TECHNIQUES INCLUDING HIGH VOLUME SUCTION WITH IRRIGATION AND A RINSE. A DENTAL EXPLORER MAY BE USED TO REMOVE ANY DENTAL MATERIAL FROM THE EMBRASURE SPACES BETWEEN THE TEETH." IN THIS CASE, IT APPEARS THAT THE DENTAL DRILL WAS USED TO REMOVE DENTAL MATERIAL FROM THE TEETH. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. ROOT CAUSE APPEARS TO BE USE ERROR. PER 510(K) SUBMISSION K173402, NEO-1002 CLINICAL VALIDATION (G170037) INVESTIGATED SERIOUS ADVERSE EVENTS AS A RESULT OF CUTTING THE CHAIRSIDE SPLIT AND FOUND NO ADVERSE EVENTS OF ANY KIND RELATED TO CHAIRSIDE SPLINT REMOVAL.

    Description of Event or Problem · 1

    FR-780, CASE (B)(4). TOOTH #29 DAMAGED DURING CHAIRSIDE PATIENT SPLINT (CPS) REMOVAL. IT WAS REPORTED IN A COMPLAINT THAT DRILLING DURING THE PROCEDURE LED TO TOOTH DAMAGE. THE PATIENT WAS REFERRED TO A RESTORATIVE DENTIST TO EVALUATE AND REPAIR THE DAMAGE. THE NEOCIS GUIDANCE SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814262 NEOCIS GUIDANCE SYSTEM DENTAL STEREOTAXIC INSTRUMENT PLV NEOCIS INC. GEN 1 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention