BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICAT IMPLANT V2.0

    MDR report key: 10331366 · Received July 28, 2020

    Report

    Report Number
    3006098230-2020-00001
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 30, 2020
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    LLZ
    PMA / PMN Number
    K192348
    Removal / Correction Number
    3006098230-2020-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SICAT IMPLANT V2.0 IS A STANDALONE SOFTWARE APPLICATION. THE DEVICE PROBLEM WAS ANALYZED AND IT WAS FOUND THAT IMPLANT PLANNING DATA EXPORTED FROM SICAT IMPLANT ARE NOT CORRECT FOR ONE SPECIFIC EXPORT FORMAT. A CODING ERROR WAS DETECTED CAUSING THE DEVICE PROBLEM. IMMEDIATE ACTION HAS BEEN TAKEN WITHIN THE LICENSING SYSTEM OF SICAT IMPLANTV 2.0 TO PREVENT NEW CUSTOMERS/USERS FROM ACTIVATING THE APPLICATION. A FIELD SAFETY NOTICE HAS BE SEND OUT TO THE USERS AND CONSIGNEES OF SICAT IMPLANT V2.0. THE DEVICE WILL BE CORRECTED IN THE FIELD BY DISTRIBUTING AND APPLYING A SOFTWARE PATCH TO REMOVE THE PROBLEM. EVALUATION RESULTS AND EVALUATION REPORT WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    SICAT IMPLANT IS A STANDALONE SOFTWARE APPLICATION, I.E. A RADIOLOGICAL VISUALIZATION SOFTWARE FOR DIAGNOSIS AND DENTAL IMPLANT PLANNING. A DENTIST FOUND THAT IMPLANT PLANNING DATA EXPORTED FROM SICAT IMPLANT ARE NOT CORRECT FOR ONE SPECIFIC EXPORT FORMAT. IF IT WERE TO RECUR, THE ERROR IN THE EXPORT FORMAT MIGHT CAUSE DENTISTS TO MANUFACTURE (OR HAVE MANUFACTURED) SURGICAL GUIDES WHICH ARE INCORRECT. USING THOSE GUIDES MIGHT CAUSE DRILLING INTO THE JAW TO BE EITHER NOT DEEP ENOUGH OR TO DEEP. A DENTIST MIGHT HAVE TO STOP A SURGICAL PROCEDURE. OR THE DRILLING WHEN TO DEEP MIGHT CAUSE DAMAGE TO STRUCTURES WITHIN THE JAW WHICH NEED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799309 SICAT IMPLANT V2.0 RADIOLOGICAL VISUALIZATION SOFTWARE FOR DIAGNOSIS AND DENTAL IMPLANT PLANNING LLZ SICAT GMBH & CO. KG SICAT IMPLANT V2.0 V2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR DENTSPLY SIRONA CERCEC SYSTEM (INLAB18 SOFTWARE)