BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART

    MDR report key: 2132366 · Received June 13, 2011

    Report

    Report Number
    8031010-2011-00080
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 19, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS APPARENTLY NO REPORT OF INJURY IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITHIN THE PAST TWO YEARS INVOLVING THIS MALFUNCTION THAT RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THIS EVENT WILL BE REEVALUATED, AS APPROPRIATE, IF FURTHER INFORMATION BECOMES AVAILABLE. 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; EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION. HOWEVER, THERE IS NO INDICATION THAT 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