BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT ACCESSGUIDE

    MDR report key: 8539330 · Received April 23, 2019

    Report

    Report Number
    3006098230-2019-00001
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 23, 2019
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    EJL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST SUSPECTED THAT TWO OF THE THREE ENDODONTIC GUIDES WERE NOT MANUFACTURED ACCORDING TO PRESCRIPTION/PLANNING. BEFORE INITIAL SHIPMENT OF THE GUIDES TO THE DENTIST, THE SLEEVE POSITIONS AND ORIENTATIONS HAD BEEN VERIFIED AT SICAT SURGICAL GUIDES LAB USING A COORDINATE MEASUREMENT MACHINE. THE FINAL PROTOCOL OF THIS PROCEDURE HAS BEEN REEVALUATED. THE PROTOCOL DOES NOT SHOW ANY RELEVANT DEVIATION OF THE ACTUAL SLEEVE POSITIONS AND ANGULATIONS WITHIN THE GUIDES COMPARED TO THE DOCTORS PLANNING OF SLEEVE POSITION AND ANGULATION. THE ACCESSGUIDES COULD NOT BE EVALUATED. THE DENTIST HAD ALREADY DEPOSED OF THE GUIDES. (B)(4).

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT ACESSGUIDE FOR PREPARING ACCESS CANALS FOR THREE ROOT CANALS FOR TOOTH #19. DRILLING THE ACCESS CANAL WENT WELL FOR THE FIRST CANAL. HOWEVER, THE DRILLINGS FOR TWO MESIAL CANALS BOTH PERFORATED THE FURCATION OF TOOTH #19. THE TOOTH PROGNOSIS IS HOPELESS. THE TOOTH HAS TO BE REMOVED DUE TO THE PERFORATION. REMARK: THE SICAT ACESSGUIDE CONSISTS OF THREE SEPARATE GUIDES, ONE GUIDE FOR EACH ACCESS CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333632 SICAT ACCESSGUIDE ENDODONTIC GUIDE; ACCESSORY TO DENTAL BUR EJL SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention MEISINGER ENDO ACCESS BURS