BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX

    MDR report key: 2514137 · Received March 22, 2012

    Report

    Report Number
    8031010-2012-00018
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    K992233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS 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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION 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 0741568

    Patients

    Seq Age Sex Outcome Treatment
    1