BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORZA PRO 1:5 FG

    MDR report key: 23334283 · Received October 20, 2025

    Report

    Report Number
    3003755849-2025-00006
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 19, 2025
    Report Date
    November 3, 2025
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    EFB
    UDI-DI
    00887919941972
    PMA / PMN Number
    K162926
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED THAT THERE IS NO DEFECT AND THAT THE HANDPIECE IS IN GOOD CONDITION. THE OVERHEATING COULD NOT BE REPRODUCED DURING THE ANALYSIS.

    Description of Event or Problem · 0

    AT THE BEGINNING OF A CROWN AND BRIDGE PREP ON TOOTH #29 THE PATIENT WAS BURNED INSIDE THE MOUTH. THEY WERE GIVEN LOCAL ANESTHETIC, PAIN MEDICINE AND ANTIBIOTICS.

    Description of Event or Problem · 0

    AT THE BEGINNING OF A CROWN AND BRIDGE PREP ON TOOTH #29 THE PATIENT WAS BURNED INSIDE THE MOUTH. THEY WERE GIVEN LOCAL ANESTHETIC, PAIN MEDICINE AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266869 FORZA PRO 1:5 FG CONTRA-ANGLE HAND PIECE EFB W&H DENTALWERK BUERMOOS GMBH 00887919941972

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other