BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS

    MDR report key: 439018 · Received January 15, 2003

    Report

    Report Number
    439018
    Event Type
    Injury
    Date Received
    January 15, 2003
    Date of Event
    November 6, 2002
    Report Date
    December 16, 2002
    Manufacturer
    SIEMENS
    Product Code
    IZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING POSTERIOR SPINAL FUSION SURGERY, A MOBILE SIEMENS FLUOROSCOPY C-ARM WAS NEEDED TO IMAGE THE EQUIDISTANCE OF THE PEDICLES. AFTER ANGLING THE C-ARM INTO THE M-POSITION, THE IMAGE INTENSIFIER MOVED DOWNWARD AND CONTACTED THE AWL TOOL, WHICH PENETRATED THE VERTEBRAL BODY. THERE WAS NO TRAUMA TO THE SPINAL NERVES OR ANY OTHER SURROUNDING TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS RADIOGRAPHIC/FLUOROSCOPY UNIT, MOBILE IZL SIEMENS SIREMOBIL COMPACT *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L