BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART W/CONTRA ANGLE EUR

    MDR report key: 24324441 · Received February 12, 2026

    Report

    Report Number
    8031010-2026-00010
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 19, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION RESULTS FOR THIS COMPLAINT ARE: DENTSPLY SIRONA INDIA. X-SMART W/CONTRA ANGLE EUR: AS PER CUSTOMER-RESISTANCE DURING ROTATION. AS PER SERVICE ENGINEER: H1004C5210500 - HEAD CAP -PROBLEM, H1004C5210150-CARTRIDGE- PROBLEM. UNDER WARRANTY INVOICE NO. (B)(4) DATED 11-10-2024. THERE WAS NO INJURY TO THE PATIENT. PROBLEM INVESTIGATION- CARTRIDGE HAVING PROBLEM, HEAD CAP IS WEAK- REPLACED CARTRIDGE, HEAD CAP. 04.02.26: CHU - REQUEST FOR VIGILANCE TO INDIA. 10.02.26: NOT REPORTABLE IN INDIA. DENTSPLY SIRONA MAILLEFER. NO CREDIT NOTE, OUT OF WARRANTY, SEE F714.112_V08:"AS OF JANUARY 1ST, WE WILL STOP PROVIDING CREDIT NOTES OR WARRANTY EXCHANGES FOR THE X SMART.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION HAS CAUSED FILE SEPARATION. SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR 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 HAS RESISTANCE DURING ROTATION. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415804 X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED EKX MAILLEFER INSTRUMENTS HOLDING SARL 0C852147/ 0C857901/0C899331/0C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown