BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMARK APEX LOCATOR

    MDR report key: 4898839 · Received July 2, 2015

    Report

    Report Number
    9611053-2015-00023
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    LQY
    PMA / PMN Number
    K131907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN NO PREVIOUS REPORT RECEIVED FOR A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST E PRESUMED THAT RECURRENCE OF THE 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 · 1

    THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPEC.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433074 PROMARK APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY TULSA DENTAL SPECIALTIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1