BEUDAMED
    FDA Adverse Event Death Summary report: N

    50K HIGH SPEED FTSWITCH DRILL

    MDR report key: 115187 · Received August 22, 1997

    Report

    Report Number
    1811755-1997-00065
    Event Type
    Death
    Date Received
    August 22, 1997
    Report Date
    December 1, 1996
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER REP, SURGEON USING HANDPIECE IN A BACK PROCEDURE AND IN THE PROCESS THE BUR WHIPPED AT A HIGH SPEED. THE BUR ENGAGED BOTH THE DURA AND THE SPINAL CORD OF THE PT SEVERING IT COMPLETELY AT THE TIME AND RENDERING THE PT PARAPALLEGIC. THE PT PROCEEDED IN THE HOSP AFTER THAT TIME TO EXPIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 50K HIGH SPEED FTSWITCH DRILL DRILL HBF STRYKER INSTRUMENTS 2296-010-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death