BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART PLUS

    MDR report key: 12954845 · Received December 7, 2021

    Report

    Report Number
    8031010-2021-00376
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 22, 2021
    Report Date
    March 30, 2022
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EGS
    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 FOR THIS COMPLAINT WAS RECEIVED AND THE INVESTIGATION/INSPECTION RESULTS FOR THIS COMPLAINT ARE RECEIVED = 1X X-SMART PLUS BEARING RETAINER H1033C1051113 1X X-SMART PLUS CARTRIDGE H1033C1051015 1X X-SMART PLUS DRIVE SHAFT H1033C1051022 1X X-SMART PLUS HEAD CAP H1033C1051050 1X X-SMART PLUS WAVE WASHER H1033C427A360 X-SMART PLUS CARTRIDGE BAD MAINTENANCE (USER) THERE IS SOME RUST ON THE CARTRIDGE.

    Additional Manufacturer Narrative · 0

    CONTRA ANGLE WON'T HOLD FILES; NO INJURY RESULTED. 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

    IT WAS REPORTED THAT X-SMART PLUS WAS NOT HOLDING FILES AND HAD BAD SOUND. THERE IS NO INJURY TO PATIENT. AS PER CUSTOMER: SOUND / FILE NOT HOLDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843986 X-SMART PLUS HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS MAILLEFER INSTRUMENTS HOLDING SARL 8689368

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown