BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART ENDO MOTOR WITH CONTRA ANGLE HANPIECE

    MDR report key: 8856639 · Received August 2, 2019

    Report

    Report Number
    8031010-2019-00120
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Report Date
    October 3, 2019
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKX
    PMA / PMN Number
    K990682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED - 1X X-SMART CARTRIDGE H1004C5210150. 1X X-SMART NECK H1004C5470220. 1X X-SMART HEAD CAP H1004C5210500. X-SMART HEAD CAP: BAD MAINTENANCE (USER). THE FILE IS HARD TO REMOVE, THIS FAILURE IS PROBABLY CAUSED BY RUST OR OTHER FOREIGN MATTER IN THE HEAD CAP. X-SMART NECK: ROTATION NOT FLUID. X-SMART CARTRIDGE: ROTATION NOT FLUID.

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED FOR A SIMILAR DEVICE 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 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 WOULD NOT HOLD FILES; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648112 X-SMART ENDO MOTOR WITH CONTRA ANGLE HANPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY MAILLEFER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1