BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSCORE EZ XTEND / A-DEC W&H SYNEA

    MDR report key: 22134340 · Received June 3, 2025

    Report

    Report Number
    3003755849-2025-00005
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    August 8, 2023
    Report Date
    June 3, 2025
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    EFB
    PMA / PMN Number
    K070663
    Removal / Correction Number
    3007007357-2025-00003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURED IN 2023. NO FURTHER INFORMATION WAS AVAILABLE. NO INVESTIGATION OF THE HIGH-SPEED HANDPIECE WAS POSSIBLE.

    Description of Event or Problem · 0

    DENTAL BUR UTILIZED BECAME DETACHED FROM THE HANDPIECE, ENTERING PATIENT'S NOSE AND RESULTING TO BEING SWALLOWED BY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397872 PROSCORE EZ XTEND / A-DEC W&H SYNEA HIGHSPEED HANDPIECE EFB W&H DENTALWERK BUERMOOS GMBH TA-98

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other