BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT OPTIGUIDE

    MDR report key: 6314252 · Received February 9, 2017

    Report

    Report Number
    3006098230-2017-00002
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    January 10, 2017
    Report Date
    February 9, 2017
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SURGICAL 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 WITHIN THE SURGICAL GUIDE COMPARED TO THE DOCTORS PLANNING OF SLEEVE POSITION AND ANGULATION. THE RETURNED SURGICAL GUIDE WAS EVALUATED USING A 3D X-RAY SCAN OF THE PATIENT, AN OPTICAL SCAN OF THE PATIENTS JAW AND A PLASTER MODEL OF THE PATIENTS JAW. A QUALITATIVE ANALYSIS SHOWS INCONSISTENCIES BETWEEN THE X-RAY SCAN, THE OPTICAL SCAN AND THE PLASTER MODEL. PROBABLE CAUSE OF EVENT: THE 3D X-RAY SCAN (TO OLD) AND/OR THE OPTICAL SCAN (DEFORMED) THAT WERE USED BY THE DENTIST FOR IMPLANT PLANNING DO NOT REPRESENT THE ACTUAL DENTITION OF THE PATIENT. AS A RESULT, THE FIT OF THE SURGICAL GUIDE WAS UNSTABLE. THE GUIDE SHOULD NOT HAVE BEEN USED FOR SURGERY.

    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 "BLUE SKY BIO MAX". HE GAVE ANESTHETIC AND HAD TO ADJUST TEETH TO GET GUIDE TO SEAT PROPERLY. BUT STILL HE WAS NEVER ABLE TO FIND A STABLE POSITION. HE NOTICED THAT THE GUIDE SEEMED TO PIVOT ON TOOTH #11 AND WAS UNSTABLE FROM THERE. HE EVEN TRIED HOLDING IT DOWN IN TWO PLACES AT THE SAME TIME. HE DECIDED TO PROCEED WITH SURGERY ANYWAY. HE DID BOTH OSTEOTOMIES USING BLUE SKY BIO COMPONENTS AND INSERTED BOTH IMPLANTS USING THE PROPER TOOLS AND TECHNIQUE THROUGH THE GUIDE. HE THEN DID A CHECK FILM AND FOUND THAT #14 IMPLANT WAS TOO CLOSE TO THE BONE WALL, FROM THE CORONAL ASPECT AND ALONG THE BODY TOWARDS THE APEX. #13 WAS PLACED AS PLANNED. HE DECIDED IT WAS TOO RISKY FOR BONE TO LEAVE #14 AND SO HE REMOVED THE IMPLANT AND PLACED HEAVY BONE GRAFTING. HE WILL ALLOW IT TO HEAL FOR A FEW MONTHS. PATIENT IS RECOVERING WELL AND FUTURE IMPLANT SHOULD BE POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98231 SICAT OPTIGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention BLUE SKY BIO MAX IMPLANT #IJH3508