BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART W/CONTRA ANGLE EUR

    MDR report key: 19116619 · Received April 16, 2024

    Report

    Report Number
    8031010-2024-00039
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    April 10, 2024
    Report Date
    May 16, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: RECEIVED = 1X X-SMART CARTRIDGE H1004C5210150. 1X X-SMART CASING ASSEMBLY H1004E2810010 SN: (B)(6). 1X X-SMART HEAD CAP H1004C5210500. 1X X-SMART NECK H1004C5470220. X-SMART CASING ASSEMBLY: SAV VARIOUS MECHANICAL PROBLEM; INSIDE OF THE HANDPIECE CASING IS BROKEN. X-SMART NECK: SAV BAD MAINTENANCE (USER); I NOTE THAT THE NECK IS RUSTED. X-SMART CARTRIDGE: SAV BAD MAINTENANCE (USER); I NOTE THAT THE CARTRIDGE IS RUSTED.

    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 WAS RETURNED AND INVESTIGATION RESULTS: AS PER SERVICE ENGINEER- H1004C5210500 - HEAD CAP -PROBLEM; H1004C5210150-CARTRIDGE- PROBLEM; H1004C5470220 - NECK- PROBLEM; H1004E2810010 -ASTING ASSEMBLY - PROBLEM; UNDER WARRANTY INVOICE NO. (B)(4),, DATED 12-12-22. THERE WAS NO INJURY TO THE PATIENT. PROBLEM INVESTIGATION-CARTRIDGE,NECK ,HEAD CAP AND CASTING ASSEMBLY -REPLACE CARTRIGDE ,NECK , HEAD CAP AND CASTING ASSEMBLY. 10.04.24: RMA COMMUNICATED TO DENTSPLY SIRONA INDIA + VIGILANCE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A X-SMART W/CONTRA ANGLE EUR STOPPED DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125849 X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED EKX MAILLEFER INSTRUMENTS HOLDING SARL 0C250449

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown