BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX PIXI APEX LOCATOR

    MDR report key: 6042781 · Received October 19, 2016

    Report

    Report Number
    8031010-2016-00093
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Report Date
    December 7, 2016
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692522 PROPEX PIXI APEX LOCATOR LOCATOR, ROOT APEX LQY DENTSPLY MAILLEFER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1