BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHODONTIC SCREWDRIVER IA-400

    MDR report key: 4340008 · Received December 15, 2014

    Report

    Report Number
    9681479-2014-00002
    Event Type
    Injury
    Date Received
    December 15, 2014
    Date of Event
    October 26, 2014
    Report Date
    December 10, 2014
    Manufacturer
    W AND H DENTALWERK BUERMOOS GMBH
    Product Code
    EKX
    PMA / PMN Number
    K100600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    INITIAL SITUATION: AFTER THE HEALING PERIOD OF 6 MONTHS THE FRAMEWORK OF THE SUPRA CONSTRUCTION ON FOUR IMPLANTS WAS PLANNED TO BE PREPARED. THEREFORE THE FOUR COVER SCREWS SHOULD HAVE BEEN UNSCREWED. UNSCREWING OF THE FIRST SCREW WAS POSSIBLE WITHOUT ANY COMPLICATION. ACCORDING TO THE USER'S STATEMENT, THE PROSTHODONTIC SCREWDRIVER CHANGED IN THE COURSE OF LOOSENING THE SECOND SCREW FROM REVERSE TO FORWARD SCREWING AND LOOSENED THE IMPLANT'S JOINT WITH THE BONE SO THAT IT HAD TO BE REMOVED. THE PROSTHODONTIC SCREWDRIVER IS DESIGNED FOR A MAX. TORQUE OF 40 NCM (+/-10%) AND THAT TORQUE VALUE IS ELECTRONICALLY LIMITED. WITHOUT THIS LIMITATION THE THEORETICAL TORQUE OF THE MOTOR IN COMBINATION WITH THE CONTRA ANGLE THEORETICALLY WOULD BE MAX. 50 NCM. THE REJECTED PROSTHODONTIC SCREWDRIVER WAS TESTED IN OUR TESTING LABORATORY AND WAS CONFIRMED TO BE TOTALLY WITHIN THE FIXED RANGE OF TOLERANCES. AN UNINTENDED AUTOMATICALLY CHANGE FROM REVERSE TO FORWARD MODE IS TECHNICALLY NOT POSSIBLE. CONSEQUENTLY A MALFUNCTION OF THE REJECTED PROSTHODONTIC SCREWDRIVER CAN BE EXCLUDED. WE ASSUME THAT THE CONCERNED IMPLANT'S SEAT IN THE BONE WAS NOT SOLID YET ("OSSEOINTEGRATED") BECAUSE AN OSSEOINTEGRATED IMPLANT NEEDS PER MM LENGTH AT LEAST 12 NCM TORQUE FOR BEING REMOVED (STUDY: MECHANICAL STABILITY OF IMMEDIATELY LOADED IMPLANTS WITH VARIOUS SURFACES AND DESIGNS: A PILOT STUDY IN DOGS" JOERG NEUGEBAUER ET AL.) THE CONCERNED IMPLANT WAS 11.5 MM LONG AND THAT MEANS THAT THE REMOVAL TORQUE, SO THE TORQUE NECESSARY TO LOOSEN THE IMPLANT/BONE CONNECTION, SHOULD BE HIGHER THAN 130 NCM. SUCH TORQUE VALUES CANNOT BE REACHED WITH THE PROSTHODONTIC SCREWDRIVER - NOT THEORETICALLY AND NOT PRACTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820463 PROSTHODONTIC SCREWDRIVER IA-400 HANDPIECE, DIRECT DRIVE EKX W AND H DENTALWERK BUERMOOS GMBH IA-400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention