BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX PIXI APEX LOCATOR

    MDR report key: 5100629 · Received September 24, 2015

    Report

    Report Number
    8031010-2015-00042
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    August 27, 2015
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND FOUND TO HAVE VARIOUS ELECTRICAL ISSUES.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROPEX PIXI APEX LOCATOR WAS GIVING INCORRECT MEASUREMENTS CAUSING AN OVER-INSTRUMENTATION AND AS A RESULT THE APICAL FORAMEN WAS PERFORATED AND BLEEDING. FURTHER INFORMATION ABOUT THE PATIENTS HAS BEEN REQUESTED AND IS PENDING AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631679 PROPEX PIXI APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY MAILLEFER NA

    Patients

    Seq Age Sex Outcome Treatment
    1