BEUDAMED
    FDA Adverse Event Other Summary report: N

    TPS DRILL

    MDR report key: 593255 · Received April 4, 2005

    Report

    Report Number
    593255
    Event Type
    Other
    Date Received
    April 4, 2005
    Date of Event
    March 23, 2005
    Report Date
    April 4, 2005
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHEN A PHYSICIAN WAS USING THE STRYKER SIDE CUTTING CARBIDE BUR IN THE STRYKER TPS DRILL DURING DENTAL EXTRACTIONS, THE END OF THE DRILL BIT BROKE OFF IN THE PATIENT'S MANDIBLE. THE SUCTION FILTER WAS EXAMINED FOR THE END OF THE DRILL BIT BUT IT WAS NOT FOUND. BLEEDING OCCURRED WHILE SEARCHING THE AREA IN THE PATIENT'S MOUTH WHERE THE DRILL BIT BROKE OFF. THE DOCTOR BELIEVED IT WAS "DOING MORE HARM THAN GOOD" SEARCHING THE WOUND AND DECIDED TO HAVE THE PATIENT GO TO DENTAL RADIOLOGY AFTER RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS DRILL TPS DRILL - SIDE CUTTING CARBIDE BUR DZI STRYKER INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR