BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMARK APEX LOCATOR

    MDR report key: 14316601 · Received May 7, 2022

    Report

    Report Number
    9611053-2022-00549
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 30, 2022
    Manufacturer
    VDW GMBH
    Product Code
    LQY
    PMA / PMN Number
    K131907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, 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 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE HOUSING TOUCHSCREEN FUNCTIONS DO NOT WORK. CANNOT NAVIGATE TO PERFORM TESTS. THE PCB PASSED ALL TESTS. THE BATTERY NEEDS REPLACED. ALL OTHER PARTS CHECK OK. NEED TO REPLACE THE HOUSING AND BATTERY.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENT. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308783 PROMARK APEX LOCATOR LOCATOR, ROOT APEX LQY VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown