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Tucson, Arizona, 28 November, 2005

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Since the 20/20 broadcast in December of 1993, there has been considerable interest in the orthopedic and neurological application of internal fixation devices into the spine. The introduction of a lag screw into the area of the spine called the pedicle, has, in a sense, revolutionized internal fixation of the spine. However, these devices, which are in fact, bone screws, have never been licensed by the FDA for use in the pedicle. So the patient/client who has had these devices implanted and who has had an unsatisfactory result are quick to blame this device.

Merely because a device is not approved by the FDA does not make its application to the human body necessarily improper. The Food & Drug Administration, is under-staffed and under-managed, and we, as consumers of health care, would not want to wait until the FDA determined what device can be used in us, or what medicine may, in fact, save our lives: doctors, based upon a sound body of evidence and based upon what is usual and customary, use drugs and devices that are not specifically approved for the purpose used on patients frequently. The question is whether the device is (1) used properly and (2) within the standard of care as based upon a consensus of the professional neurological-orthopedic surgical communities. Moreover, sometimes physicians are quick to use a device that is not approved because of a profit motive, rather than a genuine human need.

The use of pedicle screws in the spine is reasonable for serious conditions, such as slipped or subluxated vertebra (spondylollsthesis), or disrupted vertebra by tumor or fracture. Most spinal surgeons believe that this is within the standard of care, despite the fact that these are not FDA approved devices. They are medically and surgically necessary, because they stabilize the spine and allow the spinal column to stay in relative alignment until the bone heals.

Unfortunately anywhere from 10-25 percent of persons who have any kind of spinal surgery will have persistent pain and substantial disability. As an evaluator of these cases, like any other tort case, one must determine whether or not the use of the device is the proximate cause of the client/patient's disability. One must determine this, as well as whether or not the device is used within the above framework (fractures or vertebras slipped on one another).

After performing over 20 Steffe screw type of insertion cases and evaluating another 20 or so medical malpractice cases for myself and various other attorneys, the essence of the proper application of the device requires anatomical placement of the screw within the confines of this narrow bony isthmus, called the pedicle, and into a specific portion of the vertebral body. Occasionally the screw is not in the right place, and one of two things can happen. (1) The screw can either have lost its fixation insofar as being, so to speak, out in the breeze where it can't hold bone satisfactorily to hold the vertebra still, or (2) the screw can be within the neural canal or neurforamina and actually encroaching, pinching and tearing neurological structures as to cause permanent disability.

The spinal surgeon may know that the screw is not in the proper position, but he/she will rarely so state in his/her medical records. Such would be an admission. Moreover, the radiologists, who the patient/client pays to interpret these films frequently does not know where the screw belongs, and will give a nondescript reading, such as a general overview, "the screw has been placed within the pedicle and vertebral body, and appears satisfactory".

So the essence of evaluating the Steffe plate and screw case is to determine: (1) whether the application of the device has been within this generally recognized standard of care, fractured or subluxated vertebra, (2) whether the device was properly inserted into the bony elements and not impinging upon any neural elements-this requires expert reading of the radiological studies: plain x-rays, CT scans and/or magnetic resonance imaging tests. If the device has been used for an extended and nonrecognized indication, such as for a spinal fusion with degenerative disc disease, then the case may be much more difficult to prosecute if the devices are placed within the proper anatomical structures. One has to attribute the patient's pain and suffering to the application of the device in order to make a claim for medical malpractice.

  * Dr. Marrese is a practicing board certified orthopedic surgeon, lawyer and expert witness/consultant. This Article was Provided by the Technical Assistance Bureau.