BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMARK APEX LOCATOR

    MDR report key: 12918803 · Received December 2, 2021

    Report

    Report Number
    9611053-2021-00417
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 11, 2021
    Report Date
    January 12, 2022
    Manufacturer
    VDW GMBH
    Product Code
    LQY
    PMA / PMN Number
    K131907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOUSING HAS DAMAGE TO OUTER SHELL , BATTERY COVER , INTERIOR POSTS , AND TOUCH SCREEN FUNCTIONS NOT WORKING. THE PCB PASSED ALL TESTS.

    Additional Manufacturer Narrative · 0

    IN THIS EVENT IT WAS REPORTED THAT A PROMARK APEX LOCATOR PROVIDED INCORRECT MEASUREMENTS; NO INJURY RESULTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROMARK APEX LOCATOR UNIT IS NOT CONSISTENT WHEN MEASURING. TESTER WAS TRIED A FEW TIMES AND HAD VARYING PASS/FAIL RESULTS. THE DISPLAY ALSO BECAME UNRESPONSIVE. THERE WAS NO INJURY THAT OCCURRED. IN FOR REPAIR, UNIT IS OUT OF WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819736 PROMARK APEX LOCATOR LOCATOR, ROOT APEX LQY VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown