BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE

    MDR report key: 12285470 · Received August 5, 2021

    Report

    Report Number
    8031010-2021-00175
    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. SAV VARIOUS MECHANICAL PROBLEM. I NOTE THAT THE CARTRIDGE IS BLOCKED. X-SMART NECK. VARIOUS MECHANICAL PROBLEM. FOREIGN MATTER. REPLACED BY 1X X CARTRIDGE H1004C5210150, 1X X HEAD CAP H1004C5210500, 1X X NECK H1004C5470220.

    Additional Manufacturer Narrative · 1

    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
    1182694 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