BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT OPTIGUIDE

    MDR report key: 7809116 · Received August 23, 2018

    Report

    Report Number
    3006098230-2018-00005
    Event Type
    Injury
    Date Received
    August 23, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 23, 2018
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDE WAS USED FOR SURGERY WITHOUT PREVIOUSLY CHECKING EACH OF THE COMPONENTS BY THE SURGEON. THE INITIAL DRILLING WITH THE PILOT DRILL 2.0MM WAS SUCCESSFUL. FOR THE SECOND DRILLING WITH THE 2.9MM ANKYLOS EXPERTEASE A DRILL THE DESIRED DILL DEPTH COULDN´T BE REACHED. THE DRILL TOLERANCE OF THE ANKYLOS EXPERTEASE DRILLS DOESN´T MATCH WITH THE TOLERANCES OF THE SICAT 2.9MM INNER SLEEVES. THE SICAT TECHNICIAN'S ASSUMPTION THAT THE 2.9 INNER SLEEVE WOULD WORK FOR THE SURGEON WAS WRONG, AS THE SURGEON HAD USED THE STANDARD DRILLS FOR SOME PREVIOUS CASES AND NOT THE ANKYLOS EXPERTEASE GUIDE KIT AS IN THIS CASE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT OPTIGUIDE) FOR PREPARING AN OSTEOTOMY (DRILL HOLE FOR ACCOMMODATING A DENTAL IMPLANT) FOR A DENTAL IMPLANT OF TYPE ANKYLOS C/X. THE SLEEVE SYSTEM USED FOR THE SICAT SURGICAL GUIDE CONSISTS OF A FIXED OUTER SLEEVE WITH 3.5MM INNER DIAMETER AND TWO REMOVABLE INNER SLEEVES WITH 2.1MM AND 2.9MM INNER DIAMETER AND SHOULD ALLOW TO DO THE FIRST TWO DRILLS. THE DENTIST USED ANKYLOS EXPERTEASE DRILLS. THE PILOT DRILL WENT FINE. THE SECOND DRILL (ANKYLOS EXPERTEASE A 2.9MM) DID NOT FIT THRU THE INNER SLEEVE (2.9MM). THE DENTIST COULD NOT REACH THE DESIRED DRILL DEPTH. HE STOPPED THE SURGERY AND DIDN'T DELIVER THE IMPLANT. HE JUST GRAFTED THE BONE AND WILL LET IT HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651290 SICAT OPTIGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention ANKYLOS EXPERTEASE A DRILL 2.9MM