BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABC DRILL BIT 2.7MM

    MDR report key: 600034 · Received May 5, 2005

    Report

    Report Number
    2916714-2005-00019
    Event Type
    Injury
    Date Received
    May 5, 2005
    Date of Event
    February 15, 2005
    Report Date
    May 5, 2005
    Manufacturer
    AESCULAP, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS IN THE PROCESS OF DRILLING HOLES IN THE VERTEBRAL BODIES IN ORDER TO PLACE CASPAR DISTRACTION PINS. THE SCRUB TECH HANDED HIM THE FJ840R (ABC DRILL BIT-DEVICE 1) (LOADED IN THE ANGLED HANDPIECE OF THE HILAN DRILL) AND THE FF907R (DISTRACTION PIN DRILL GUIDE-DEVICE 3). THE SURGEON PROCEEDED TO DRILL THE HOLE, THE DRILL PROCEEDED TO PASS BEYOND THE POSTERIOR CORTEX, PAT THE PLL (POSTERIOR LATERAL LIGAMENT) AND INTO THE SPINAL CORD. SURGERY PROLONGED APPROXIMATELY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABC DRILL BIT 2.7MM DRILL BIT HTW AESCULAP, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN