BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL BURR

    MDR report key: 21935363 · Received April 30, 2025

    Report

    Report Number
    MW5169652
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 22, 2025
    Report Date
    April 23, 2025
    Manufacturer
    DENTSPLY SIRONA INC
    Product Code
    DZC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROCEDURE: CARIES REMOVAL AND STAINLESS-STEEL CROWN PLACEMENT ON UR PRIMARY SECOND MOLAR. DURING DISTAL INTERPROXIMAL PREP, CUTTING HEAD OF 169 BROKE (1MM FRAGMENT) WITHIN SULCUS. UNABLE TO BE LOCATED INTRAORALLY VIA CLINICAL EXAM OR INTRAORAL RADIOGRAPH. ISODRY (ISOLATION SYSTEM) WAS IN PLACE THROUGHOUT ENTIRETY OF TREATMENT. PATIENT DID NOT DISPLAY ANY SIGNS OF RESPIRATORY DISTRESS. COMPLETED DENTAL TREATMENT WITH DIFFERENT 169 BUR. PATIENT WAS ESCORTED TO CHP ED FOR CHEST X-RAY TO RULE OUT INGESTION/ASPIRATION. FG 169 (MIDWEST ONCE) - REF# (B)(4) / LOT# 1604943 / EXPIRATION 12-2029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190910 DENTAL BURR WIRE, ORTHODONTIC DZC DENTSPLY SIRONA INC 1604943

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown