BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART

    MDR report key: 2033781 · Received March 23, 2011

    Report

    Report Number
    8031010-2011-00020
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    October 28, 2010
    Report Date
    February 24, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    YM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE WAS NO INJURY IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT REC'D WITHIN THE PAST TWO YEARS INVOLVING THIS MALFUNCTION THAT RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CRF 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 IS AVAILABLE FOR EVALUATION, THOUGH, HAS NOT BEEN RETURNED AS OF THIS REPORT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1