BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDE WIRE, DUAL BLUNT ENDS

    MDR report key: 503160 · Received December 23, 2003

    Report

    Report Number
    2184052-2003-00025
    Event Type
    Other
    Date Received
    December 23, 2003
    Date of Event
    November 24, 2003
    Report Date
    December 23, 2003
    Manufacturer
    CENTERPULSE SPINE-TECH
    Product Code
    FZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADMITTED TO SURGERY IN 2003 FOR POSTERIOR IMPLANTATION OF AN ST360 SPINAL FIXATION SYSTEM IN THE LOWER LUMBAR REGION. A 0.44 INCH DIAMETER BY FIVE INCH LONG GUIDE WIRE (7010-0088-01) WAS OBSERVED, ON IMAGES JUST PRIOR TO CLOSURE OF THE PT, PROTRUDING THROUGH THE ANTERIOR OF THE L5 VERTEBRAE. THE PT WAS CLOSED AND PLACED ON THEIR BACK IN ORDER TO REMOVE THE GUIDE WIRE ANTERIORLY. THE PT WAS CHECKED, IN THE OPERATING ROOM, FOR ANY SIGNS OF TRAUMA THAT MAY HAVE BEEN CAUSED BY THE PROTRUDING GUIDE WIRE. THE PT DID NOT SHOW ANY SIGNS OF TRAUMA OR ADVERSE ATTRIBUTABLE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE, DUAL BLUNT ENDS GENERAL SURGICAL INSTRUMENTATION FZX CENTERPULSE SPINE-TECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R