BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX IQ APEX LOCATOR

    MDR report key: 10488743 · Received September 3, 2020

    Report

    Report Number
    8031010-2020-00168
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Report Date
    August 23, 2021
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROPEX IQ X-SMART IQ MEASUREMENT CABLE. VARIOUS CABLE PROBLEM. BAD CONTACT.

    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. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY SIRONA. 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 · 1

    IN THIS EVENT IT WAS REPORTED THAT A X-SMART IQ, WHEN USED IN COMBINATION WITH A PROPEX IQ APEX LOCATOR, WAS GIVING INCORRECT MEASUREMENTS; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951028 PROPEX IQ APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY MAILLEFER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1