BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE

    MDR report key: 12285469 · Received August 5, 2021

    Report

    Report Number
    8031010-2021-00177
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Report Date
    October 12, 2021
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKX
    PMA / PMN Number
    K990682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT NO INJURY RESULTED. X-SMART CARTRIDGE. VARIOUS MECHANICAL PROBLEM. I NOTE THAT THE CARTRIDGE IS BLOCKED. REPLACED BY 1X X NECK H1004C5470220, 1X X CARTRIDGE H1004C5210150, 1X X HEAD CAP H1004C5210500.

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED FOR 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 · 1

    IN THIS EVENT IT WAS REPORTED THAT A X-SMARTCONTRA ANGLE DID NOT HOLD FILES. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182693 X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY MAILLEFER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1