BEUDAMED
    FDA Adverse Event Death Summary report: N

    THIN RASP, 12 X 20MM

    MDR report key: 2848454 · Received November 21, 2012

    Report

    Report Number
    3004142400-2012-00025
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    November 7, 2011
    Report Date
    October 25, 2012
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BASED ON INFO OBTAINED BY GLOBUS MEDICAL, WHICH THE COMPANY MAY NOT HAVE BEEN FULLY ABLE TO INVESTIGATE PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. GLOBUS HAS PROVIDED AS MUCH INFO AS AVAILABLE TO THE COMPANY AS OF THE DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE PRODUCT DESCRIBED IN THIS REPORT HAD ANY DEFECTS OR MALFUNCTIONED. IT IS BELIEVED USER ERROR CAUSED THE PT DEATH. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AN AUTOPSY WAS PERFORMED AND IT IS THE OPINION OF THE MEDICAL EXAMINER THAT THE PT DIED AS A RESULT OF EXSANGUINATION DUE TO INCISED WOUNDS OF THE ABDOMINAL AORTA.

    Description of Event or Problem · 1

    A PT UNDERWENT SURGERY ON (B)(6) 2011. DURING THE SURGERY, PITUITARY RONGEURS WERE USED TO REMOVE A PORTION OF THE DISC MATERIAL. THE DISC SPACE WAS FOUND TO BE NARROW. A RASP WAS USED TO ENTER THE DISC SPACE. THE RASP NICKED THE ANTERIOR ASPECT CAUSING A VASCULAR INJURY RESULTING IN MASSIVE BLOOD LOSS. THE PT DIED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THIN RASP, 12 X 20MM RASP 12 X 20MM KWP GLOBUS MEDICAL, INC. 675.510 WEL180AB

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death