BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT ACCESSGUIDE

    MDR report key: 8124824 · Received December 3, 2018

    Report

    Report Number
    3006098230-2018-00007
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    November 5, 2018
    Report Date
    December 3, 2018
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    EJL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST SUSPECTED THAT THE TWO ENDODONTIC GUIDES WERE NOT MANUFACTURED ACCORDING TO PRESCRIPTION/PLANNING. THE DENTIST HAS RETURNED THE SUSPECTED SICAT ACCESSGUIDE(S) BACK TO SICAT FOR EVALUATION. 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 RETURNED SICAT ACESSGUIDE(S) WERE EVALUATED USING A 3D PRINTED MODEL OF THE PATIENTS JAW. THE SEATING OF THE GUIDES IS STABLE. THE ACCESS HOLES ARE IN THE OCCLUSION AT THE POSITIONS AND ANGULATIONS PLANNED BY THE DENTIST. THE INSPECTION DOES NOT GIVE ANY INDICATION FOR AN INCORRECT ARRANGEMENT OF THE SLEEVES OR OF ANY OTHER DEVICE PROBLEM.

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT ACESSGUIDE FOR PREPARING ACCESS CANALS FOR TWO ROOT CANALS OF TOOTH #4. HOWEVER, THE DRILLINGS WERE MORE DISTAL FOR THE BUCCAL CANAL THAN HE PLANNED AND THE ACCESS HOLE FOR THE LINGUAL CANAL WAS ALSO TOO FAR DISTAL. THE ROOT CANAL COULD NOT BE FOUND. THE TOOTH HAD TO BE EXTRACTED. REMARK: THE SICAT ACESSGUIDE CONSISTS OF TWO SEPARATE GUIDES, ONE GUIDE FOR EACH ACCESS CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964638 SICAT ACCESSGUIDE ENDODONTIC GUIDE; ACCESSORY TO DENTAL BUR EJL SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention MEISINGER ENDO ACCESS BURS