BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT OPTIGUIDE

    MDR report key: 6275505 · Received January 25, 2017

    Report

    Report Number
    3006098230-2017-00001
    Event Type
    Injury
    Date Received
    January 25, 2017
    Date of Event
    December 15, 2016
    Report Date
    January 25, 2017
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST SUSPECTED THAT THE SURGICAL GUIDE WAS NOT MANUFACTURED ACCORDING TO PRESCRIPTION/PLANNING. THE DENTIST HAS RETURNED THE SUSPECTED DENTAL GUIDE BACK TO SICAT FOR EVALUATION. BEFORE INITIAL SHIPMENT OF THE GUIDE TO THE DOCTOR, THE SLEEVE POSITION 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 POSITION AND ANGULATION COMPARED TO THE DOCTORS PLANNING OF SLEEVE POSITION AND ANGULATION. THE RETURNED SURGICAL GUIDE WAS EVALUATED USING OPTICAL SCANS OF THE SURGICAL GUIDE AND A PLASTER MODEL OF THE PATIENTS JAW. A QUANTITATIVE ANALYSIS OF THE OVERLAYS OF OPTICAL SCANS AND X-RAY SCANS DOES NOT GIVE AN INDICATION FOR AN INCORRECT PLACEMENT OR ANGULATION OF THE SLEEVE COMPARED TO THE DOCTORS PLANNING. PROBABLE CAUSE OF EVENT: DENTIST INSERTED DRILL INTO SLEEVE WHEN DRILL WAS ALREADY IN ROTATION. DRILL CAUSED SHEDDING OF SLEEVE, WHICH ALLOWED FOR AN INCORRECT ANGULATION OF THE DRILL.

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT OPTIGUIDE) FOR PREPARING THE OSTEOTOMIES (DRILL HOLE FOR ACCOMMODATING A DENTAL IMPLANT) FOR TWO DENTAL IMPLANTS OF TYPE "IMPLANT DIRECT, LEGACY3 SBM". WITH GUIDE SEATED WELL, GUIDE PATH FOR TOOTH NUMBER 26 WAS MORE TO THE DISTAL (CLOSER TO TOOTH #27) THAN PLANNED. WHILE THE DENTIST TRIED TO CORRECT THE PATH IN SUBSEQUENT ROUNDS HE WAS UNABLE AND THE FINAL POSITION OF THE IMPLANT WAS TOO DISTAL. THE IMPLANT WAS REMOVED AND OSTEOTOMY SITE GRAFTED. HE WILL HAVE TO RETURN TO THE SITE IN THE FUTURE TO PLACE THE IMPLANT. TOOTH 23 WENT EXACTLY AS PLANNED. THE GUIDE WAS SEATED EXACTLY THE SAME FOR EACH OSTEOTOMY. THE DENTIST WANTS TO KNOW IF THE PLACEMENT OF THE DRILL SLEEVE WITHIN THE SURGICAL GUIDE FOR TOOTH 26 WAS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60223 SICAT OPTIGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention IMPLANT DIRECT, LEGACY3 SBM (SERIAL NO. (B)(4))