BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMATIC LUX3 CONTRA ANGLE 25LHA

    MDR report key: 3123997 · Received May 15, 2013

    Report

    Report Number
    3003637274-2013-00016
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    February 15, 2013
    Report Date
    April 12, 2013
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT THE BACK CAP BUTTON ON HANDPIECE COVER IS MISSING. FUNCTIONAL PROBLEMS OR DENTS ON THE PRODUCT WAS NOT FOUND. THE FINAL ROOT CAUSE CANNOT BE IDENTIFIED, BECAUSE THE BACK CAP BUTTON IS MISSING. FACTOR THAT MAY CONTRIBUTE TO THE BACK CAP BECOMING LOOSE ARE EXCESSIVE HANDLING OF THE PRODUCT, WEAR, ETC. THE PRODUCT WAS MORE THAN 10 YEAR IN USE. THE USER INSTRUCTION REQUIRES A VISUAL AND FUNCTIONAL TEST PRIOR TO EACH TREATMENT TO ENSURE THAT THE HANDPIECE IS RUNNING WITHIN SPEC.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE BACK CAP OF A HANDPIECE CAME OFF AND WAS SWALLOWED BY A PT. NO MEDICAL CARE WAS GIVEN TO PT. (B)(6) (DENTIST ASSISTANT) SAID PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214545 INTRAMATIC LUX3 CONTRA ANGLE 25LHA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LHA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR