BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART

    MDR report key: 2020023 · Received March 9, 2011

    Report

    Report Number
    8031010-2011-00017
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 10, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    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 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 U.S., IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE WHEN TAKING INTO ACCOUNT COMPOSITION AND INDICATIONS FOR USE. THE DEVICE WAS RETURNED AND EVALUATED AND WAS FOUND TO HAVE A CABLE DISCONNECTED FROM THE PLUG. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    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 3255U911R

    Patients

    Seq Age Sex Outcome Treatment
    1