BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX PIXI APEX LOCATOR

    MDR report key: 6091493 · Received November 9, 2016

    Report

    Report Number
    8031010-2016-00101
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Report Date
    January 18, 2017
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO INJURY HAS BEEN REPORTED 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 21 CFR PART 803. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE WHEN TAKING INTO ACCOUNT COMPOSITION AND INDICATIONS FOR USE. 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 SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROPEX PIXI APEX LOCATOR WAS GIVING INCORRECT MEASUREMENTS; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742511 PROPEX PIXI APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY MAILLEFER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1