BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION-TORQUE PUSH BUTTON

    MDR report key: 4170737 · Received September 22, 2014

    Report

    Report Number
    2916440-2014-00001
    Event Type
    Other
    Date Received
    September 22, 2014
    Date of Event
    July 24, 2014
    Report Date
    September 11, 2014
    Manufacturer
    LARES RESEARCH
    Product Code
    EFB
    PMA / PMN Number
    K780038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE DEVICES WERE RETURNED FOR EVAL. SERIAL NUMBER (B)(4): HANDPIECE MANUFACTURE DATE 04/2014; NO PROBLEMS OR DEFECTS IDENTIFIED. SERIAL NUMBER (B)(4): HANDPIECE MANUFACTURE DATE 04/01/2014; NO PROBLEM OF DEFECTS IDENTIFIED. SERIAL NUMBER (B)(4): HANDPIECE MANUFACTURE DATE 04/2014; PUSH BUTTON CHUCK MANUFACTURE DATE CODE 03/14. RETURNED HANDPIECE WAS FUNCTIONAL AS RETURNED TO LARES. VISUAL EVAL IDENTIFIED THAT THE HEAD CAP ASSEMBLY WAS DEFORMED DUE TO IMPACT AND WAS OUT OF POSITION. THIS PREVENTED THE PUSH BUTTON FROM SEATING SQUARELY IN THE HEAD CAP. THE INTERMITTENT TILT STICK OF THE BUTTON REDUCED THE INTERNAL CHUCK SPRING TO BUTTON RETAINING CROWN CLEARANCE. A SMALL AMOUNT OF DYNAMIC CONTACT MARKING WAS VISIBLE ON ONE OF THE FOUR BUTTON RETENTION CROWN FEATURES AND ON ONE OF THE PUSH BUTTON CHUCK SPRINGS. THE INTERMITTENT DYNAMIC CONTACT MAY HAVE GENERATED FRICTIONAL HEAT IN THE HEAD OF THE HANDPIECE AS REPORTED BY THE USER. CONCLUSION: BASED ON THE ONE RETURNED PRODUCT CONDITION, THE HEATING OF THE HANDPIECE WAS DUE TO DAMAGE SUSTAINED BY THE HANDPIECE HEAD CAP AND SUBSEQUENT INTERMITTENT PUSH BUTTON DYNAMIC CONTACT WITH THE PUSH BUTTON CHUCK SPRINGS. NO HANDPIECE MATERIAL OR WORKMANSHIP DEFECTS WERE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER/END USER DESCRIBED THE DENTAL HANDPIECE DEVICE WOULD GET HOT DURING USE AND TWO UNK PT'S CHEEKS WERE BURNED. THREE DEVICES WERE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586311 PRECISION-TORQUE PUSH BUTTON AIR DRIVEN DENTAL HANDPIECE EFB LARES RESEARCH 557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other