BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART PLUS

    MDR report key: 16673643 · Received April 4, 2023

    Report

    Report Number
    8031010-2023-00780
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Report Date
    May 31, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    DENTSPLY SIRONA HAS NOT RECEIVED ANY REPORTS OF DEATH OR SERIOUS INJURY FOR A BUR OR FILE WALKOUT MALFUNCTION SINCE FEBRUARY 2020. DENTSPLY SIRONA HAS GATHERED HISTORICAL COMPLAINT DATA THAT INDICATES THE INCIDENCE OF THE BUR OR FILE WALKOUT MALFUNCTION OF OUR DENTAL HANDPIECES HAS A COMPLAINT RATE OF (B)(4)%, AND A SERIOUS INJURY RATE OF (B)(4)% SINCE THE FIRST INJURY IN 1997. THUS, THE PROBABILITY OF SERIOUS INJURY AS A RESULT OF THIS MALFUNCTION IS TRULY REMOTE AND THEREFORE NOT LIKELY. THEREFORE, DENTSPLY SIRONA WILL CEASE MALFUNCTION REPORTING FOR BUR OR FILE WALKOUT EVENTS WITH OUR DENTAL HANDPIECES, WITH THIS BEING OUR FINAL MALFUNCTION INDIVIDUAL REPORT. RECURRENCE OF A SERIOUS INJURY OR DEATH FOR THIS MALFUNCTION WILL TRIGGER THE RESUMPTION OF MANDATORY REPORTING, PER 21CFR PART 803.50.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO INJURY. INVESTIGATION RESULTS: RECEIVED = 1X X-SMART PLUS CARTRIDGE H1033C1051015. X-SMART PLUS CARTRIDGE SAV VARIOUS MECHANICAL PROBLEM THE ROTATION OF THE FILE IS DIFFICULT BECAUSE THE BALL BEARING IS DAMAGED. REPLACED 1X XP CARTRIDGE H1033C1051015.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A X-SMART PLUS WON'T HOLD FILES. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR AND FURTHER INFORMATION REQUESTED.

    Description of Event or Problem · 0

    FURTHER INFORMATION RECEIVED INDICATING THAT NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385944 X-SMART PLUS HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS MAILLEFER INSTRUMENTS HOLDING SARL 01764319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown