BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART

    MDR report key: 2022909 · Received February 16, 2011

    Report

    Report Number
    8031010-2011-00008
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    January 17, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITHIN THE PAST TWO YEARS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE WHEN TAKING INTO ACCOUNT COMPOSITION AND INDICATIONS FOR USE. THE DEVICE WAS RETURNED AND THE DISPLAY, MOTOR, BATTERY AND CONTRA-ANGLE WERE ALL EVALUATED AND PASSED.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT AN X-SMART DUAL APEX LOCATOR PROVIDED INCORRECT MEASUREMENTS; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-SMART LQY DENTSPLY MAILLEFER 5352U1007R

    Patients

    Seq Age Sex Outcome Treatment
    1