PEEK Spacers used in Spinal Fusion

MEDTRONIC CORNERSTONE PSR/PEEK SPACERS

This serves to inform you, as a prospective cervical surgery patient, that I will likely be using a product called PEEK. The formal name for this product is Medtronic Cornerstone PSR/PEEK intervertebral body spacer. PEEK spacers have been used successfully in orthopedic and spine work for many years. They are FDA approved for use in the spine . Of note, they are not specifically designing and marketing PEEK and other spacers for the cervical spine.

The use of this spacer in the cervical spine is referred to as an *off-label use. This product has been well tested in the lumbar spine and other parts of the body in terms of orthopedic and spinal work. I have the utmost confidence in this product and would not be using it I thought otherwise. PEEK is currently used by other prominent cervical spine surgeons locally as well.

This information serves to formally advise you that this is an *off label use. The advantage of this product will likely be better product life, lack of collapse, lower rate of graft failure, and complete independence from concerns over transmission of communicable diseases from cadaver grafting material.

If you have any questions regarding this product, please direct them to Dr. Hope.

*Definition of Off-Label use: In the United States, the regulations of the Food and Drug Administration (FDA) permit physicians to prescribe approved drug or device for other than their intended indications. This practice is known as off-label use.