BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART

    MDR report key: 2112787 · Received April 29, 2011

    Report

    Report Number
    8031010-2011-00050
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO REPORT OF INJURY IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED IN THE PAST TWO YEARS WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS CRITERIA FOR REPORTABILITY.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A 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 0475U0903R

    Patients

    Seq Age Sex Outcome Treatment
    1