BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX

    MDR report key: 2445557 · Received February 1, 2012

    Report

    Report Number
    8031010-2012-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    November 25, 2011
    Report Date
    January 4, 2012
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    K992233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 INFO BECOMES AVAILABLE. ADD'L INFO REGARDING THE PT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A PROPEX II APEX LOCATOR PROVIDED INCORRECT MEASUREMENTS; EVENT OUTCOME IS UNKNOWN AS OF THIS REPORT. HOWEVER, THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPEX LQY DENTSPLY MAILLEFER

    Patients

    Seq Age Sex Outcome Treatment
    1