BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMARK APEX LOCATOR

    MDR report key: 6215796 · Received December 30, 2016

    Report

    Report Number
    9611053-2016-00066
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    January 26, 2017
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    LQY
    PMA / PMN Number
    K131907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DEEP INVESTIGATED WITH THE RESULT THAT NO FAULT HAS BEEN FOUND. SOFTWARE UPDATE ACCOMPLISHED. COMPLETE CHECK WITHOUT ERRORS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCONSISTENT MEASUREMENTS. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865403 PROMARK APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1