BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART W/CONTRA ANGLE EUR

    MDR report key: 14564722 · Received June 1, 2022

    Report

    Report Number
    8031010-2022-00569
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 20, 2022
    Report Date
    November 30, 2022
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKX
    PMA / PMN Number
    K990682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THERE IS NO INDICATION THAT SERIOUS INJURY RESULTED IN THIS EVENT, 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. AFTER INSPECTION, THE CARTRIDGE, NECK AND HEAD CAP WERE REPLACED.

    Additional Manufacturer Narrative · 0

    RECEIVED: 1X X-SMART CARTRIDGE H1004C5210150. 1X X-SMART HEAD CAP H1004C5210500. 1X X-SMART NECK H1004C5470220. X-SMART CARTRIDGE: SAV VARIOUS MECHANICAL PROBLEM. THE FILE IS HARD TO REMOVE.

    Description of Event or Problem · 0

    IN THIS EVENT IT WAS REPORTED THAT A X-SMART STOPPED DURING USE. THE FILE GOT STUCK. THERE WAS NO PATIENT'S INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306249 X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED EKX MAILLEFER INSTRUMENTS HOLDING SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown