BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX PIXI APEX LOCATOR

    MDR report key: 4898860 · Received July 2, 2015

    Report

    Report Number
    8031010-2015-00025
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPEC. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PT OUTCOME.

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT A 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, 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.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROPEX PIXI APEX LOCATOR WAS GIVING INCORRECT MEASUREMENTS; THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT YET AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433191 PROPEX PIXI APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY MAILLEFER NA

    Patients

    Seq Age Sex Outcome Treatment
    1