BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBIDE

    MDR report key: 3079663 · Received April 15, 2013

    Report

    Report Number
    3079663
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DENTAL DRILL BURR (ZB 104) BROKE DURING CASE. THE DRILL TIP WAS SUCKED INTO CANISTERS. DRILL TIP NOT FOUND. X-RAY ORDERED FOR CHEST AND RIGHT MANDIBLE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160898 CARBIDE DRILL, BURR HTT MICROAIRE SURGICAL INSTRUMENTS, LLC * 0113214852

    Patients

    Seq Age Sex Outcome Treatment
    1 *