BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMATIC LUX3 CONTRA ANGLE 25LHA

    MDR report key: 2572542 · Received May 8, 2012

    Report

    Report Number
    3003637274-2012-00025
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 1, 2011
    Report Date
    April 10, 2012
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT THE HANDPIECE HAD A MEDIUM RESIDUE. THIS SHOWS THAT THE REPROCESSING IS NOT CARRIED OUT LIKE REQUESTED. THE BEARINGS HAVE BEEN GRINDING, VIBRATING AND COMING APART, WHICH IS THE RESULT OF A NORMAL WEAR PROCESS. THE HANDPIECE HAS BEEN >5 YEARS IN USE SINCE THE LAST SVC CHECK! THE USER INSTRUCTION STATES FOLLOWING: DUE TO INCREASE TORQUE AND SPEED, POORLY MAINTAINED, DAMAGED, OR MISUSED HANDPIECES CAN POTENTIALLY GENERATE FRICTIONAL HEAT CAPABLE OF CAUSING SERIOUS BURN INJURIES TO THE PT. THE FOLLOWING GUIDELINES ARE ESSENTIAL FOR THE SAFE OPERATION OF ELECTRIC MICROMOTORS HANDPIECES: TEST RUN HANDPIECE ATTACHMENT, INSPECTING FOR HEAT, EXCESSIVE NOISE OR VIBRATION. IMMEDIATELY STOP USING ANY SUSPECT HANDPIECE. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HAND PIECE HEATED UP AND BURNED THE PT ON THE CHEEK TO THE SIZE OF A NICKEL. THE DENTIST DID NOT GIVE OR PRESCRIBE ANYTHING FOR THE BURN. PT WAS TOLD TO DO WARM SALT WATER RINSES AND DID HEAL WELL. DENTAL OFFICE DOES NOT RECALL THE NAME OF THE PT, HENCE ONLY GENDER IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMATIC LUX3 CONTRA ANGLE 25LHA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LHA

    Patients

    Seq Age Sex Outcome Treatment
    1