BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTTORQUE S609 C

    MDR report key: 3955791 · Received June 25, 2014

    Report

    Report Number
    3003637274-2014-00023
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 5, 2014
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT THE BEARING HAVE BEEN GRITTY. THE BACK CAP HAD A DENT WHICH CAUSED THE BACK CAP BUTTON TO STICK IN. IF THE BACK CAP BUTTON STICKS IN IT CAUSES UNUSUAL INNER FRICTION AND THEREFORE A FAST INCREASE OF TEMPERATURE. THE DENT SHOWS THAT THE HANDPIECE RECEIVED A STRONG HIT, E.G. DROPPING DURING REPROCESSING. THE CONDITION OF THE BEARINGS IS DUE TO WEAR PROCESS. IT IS LIKELY THAT DUE TO THE HIGHER TEMPERATURE A STRONGER WEAR PROCESS TOOK PLACE. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT ON TOOTH #4 THE HANDPIECE HEATED UP AND CAUSED A BURN ON CHEEK TO ABOUT THE SIZE OF THE BACK CAP. THE PT WAS INSTRUCTED TO DO WARM SALT/WATER RINSES BUT DID NOT GET ANY MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370613 SMARTTORQUE S609 C DENTAL HANDPIECE EFB KAVO DENTAL GMBH S609 C

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR