BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETECT APEX LOCATOR

    MDR report key: 5100619 · Received September 24, 2015

    Report

    Report Number
    2320721-2015-00020
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    August 27, 2015
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    LQY
    PMA / PMN Number
    K121206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER WAS NOT PROVIDED FOR A DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A DETECT APEX LOCATOR PROVIDED INCORRECT MEASUREMENTS, POSSIBLY CAUSING OVER-INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632820 DETECT APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY TULSA DENTAL SPECIALTIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1