BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 6348615 · Received February 22, 2017

    Report

    Report Number
    3006098230-2017-00003
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 21, 2017
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DOES NOT GIVE ANY INDICATION FOR A MALFUNCTION OR FAULT OF THE SICAT CLASSICGUIDE AS MANUFACTURED BY SICAT. THE GUIDE IS REPRESENTING THE DENTISTS PLANNING AND WAS MANUFACTURED ACCORDING TO THE PLANNING AND PRESCRIPTION OF THE DENTIST. THE 3D X-RAY SCAN USED FOR IMPLANT PLANNING SEEMS TO SHOW SEVERE ARTEFACTS, COMPLICATING A PRECISE PLANNING OF THE IMPLANT POSITIONS BY THE DENTIST. IMPLANT #5 AND IMPLANT #10 HAVE NOT BEEN PLANNED AT OPTIMUM POSITIONS.

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT CLASSICGUIDE) FOR PREPARING THE OSTEOTOMIES (DRILL HOLE FOR ACCOMMODATING A DENTAL IMPLANT) FOR FOUR DENTAL IMPLANTS OF TYPE "ZIMMER DENTAL TSVT MTX TSVTB8". THIS WAS AN EDENTULOUS PATIENT. THE OSTEOTOMY FOR IMPLANT ADA 5 ENDED UP IN THE INCORRECT POSITION. THE DENTIST HAD TO BONE GRAFT THIS AREA. THE IMPLANT AT ADA 10 WASN'T STABLE, SO THE DENTIST HAD TO BONE GRAFT THAT AREA AS WELL. THE DENTIST CONFIRMED THE FIT AND THE OTHER TWO IMPLANTS WERE JUST FINE. THE DENTIST WILL GO BACK TO THE PATIENTS IN A COUPLE MONTHS ONCE THE GRAFTS ARE HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132294 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT ZIMMER DENTAL TSVT MTX TSVTB8