BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART W/CONTRA ANGLE EUR

    MDR report key: 16642507 · Received March 30, 2023

    Report

    Report Number
    8031010-2023-00774
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Report Date
    April 13, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED = 1X X-SMART CHARGER EUR A100700000200. 1X X-SMART CONTRA ANGLE 16:1 A100601600000 SN: (B)(6) -(B)(6). 1X X-SMART HAND PIECE A100500000100 SN: (B)(6). 1X X-SMART UNIT SN: (B)(6). X-SMART MOTOR ASSEMBLY. SAV VARIOUS MECHANICAL PROBLEM. THE INSIDE SCREW OF MOTOR IS BROKEN, THEREFORE THE MOTOR HEAD IS NO LONGER FIXED TO THE MOTOR BODY. X-SMART HEAD CAP. SAV BAD MAINTENANCE (USER). THERE IS SOME FOREIGN MATTER ON THE HEAD CAP. X-SMART BATTERY. SAV BATTERY LEVEL TOO LOW TO BE RECHARGED. THE BATTERY VOLTAGE IS TOO LOW. WITH THIS VOLTAGE: IT IS IMPOSSIBE TO CHARGE THE BATTERY AND IT IS IMPOSSIBLE TO TURN ON THE DEVICE. THE CAUSE OF THIS PROBLEM IS PROBABLY A TOO LONG STORAGE. X-SMART CARTRIDGE. SAV VARIOUS MECHANICAL PROBLEM I NOTE THAT THE CARTRIGDE IS BLOCKED.. X-SMART NECK. SAV VARIOUS MECHANICAL PROBLEM. FOREIGN MATTER. REPLACED 1X X HAND PIECE A100500000100 (B)(6). 1X X CHARGER EUR A100700000200. 1X X CONTRA ANGLE 16:1 A100601600000 (B)(6). 1X X UNIT (B)(6).

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED 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 IS REPORTED THAT A X-SMART W/CONTRA ANGLE EUR AUTOREVERSE WAS DEFECTIVE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173438 X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED EKX MAILLEFER INSTRUMENTS HOLDING SARL 08142243-08142433, 08232730, 0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown