BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX IQ APEX LOCATOR

    MDR report key: 12171013 · Received July 14, 2021

    Report

    Report Number
    8031010-2021-00138
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Report Date
    October 12, 2021
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT 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. PROPEX IQ X-SMART IQ MEASUREMENT CABLE. DAMAGED CONNECTOR. CONNECTOR BROKEN (2 PARTS) BY MISUSE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT WHILE USING A X-SMART IQ IN CONJUNCTION WITH A PROPEX IQ APEX LOCATOR, THE DEVICE WAS GIVING INCORRECT MEASUREMENTS. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061367 PROPEX IQ APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY MAILLEFER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1