BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART W/CONTRA ANGLE EUR

    MDR report key: 13417271 · Received February 1, 2022

    Report

    Report Number
    8031010-2022-00435
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 20, 2022
    Report Date
    May 17, 2022
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    DEVICE WAS RECEIVED AND INSPECTED. THE INVESTIGATION RESULTS FOR THIS COMPLAINT ARE: FOUND THAT ROTATION NOT FLUID. 1X X-SMART CARTRIDGE, 1X X-SMART CASING ASSEMBLY, 1X X-SMART HEAD CAP AND 1X X-SMART MOTOR ASSEMBLY REPLACED.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH 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 RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT WAS REPORTED THAT AN X-SMART CONTRA ANGLE WON'T HOLD FILES; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165251 X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED EKX MAILLEFER INSTRUMENTS HOLDING SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown