BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART PLUS

    MDR report key: 16232915 · Received January 24, 2023

    Report

    Report Number
    8031010-2023-00730
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Report Date
    March 15, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RECEIVED: 1X X-SMART PLUS CONTRA-ANGLE 6:1 A103300000000 SN: (B)(6). 1X X-SMART PLUS HANDPIECE A103400000300 SN: (B)(6). 1X X-SMART PLUS MOTOR HANDPIECE STAND A103400000400 1X X-SMART PLUS UNIT SN: (B)(6). 1X X-SMART PLUS UNIV.AC.ADAPTER A103400000200 SN: (B)(6). X-SMART PLUS CARTRIDGE SAV VARIOUS MECHANICAL PROBLEM FILES CANNOT LOCK BECAUSE HOOK OF CARTRIDGE IS DAMAGED.

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A X-SMART PLUS WOULD NOT HOLD FILES. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7289 X-SMART PLUS HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS MAILLEFER INSTRUMENTS HOLDING SARL 01310264

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown