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Patient Information SP-Fix Spinous Process Fixation System

Table of Contents Anatomy of the Spine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 What is Degenerative Disc Disease?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 What is Spondylolisthesis?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 How the SP-Fix™ Spinous Process Fixation System Works. . . . . . . . . . 6 How is the Procedure Performed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 What Should I Expect with My Recovery? . . . . . . . . . . . . . . . . . . . . . . . . 8...

Spinous Process Fixation System Patient Information This brochure will help you understand more about: • General conditions of the spine • Information about surgical treatment • What to expect from surgery The decision to receive medical treatment is individualized to the patient and the patient’s symptoms. The information presented within this brochure may not apply to your condition, treatment or its outcome, as surgical techniques vary and complications can occur. It is important to discuss the viability of this procedure with your physician to decide whether this treatment option is...

Cervical Area Thoracic Area SP-Fix™ Patient Informatio

Anatomy of the Spine The spine is made up of vertebrae and is divided into 3 main sections: • Cervical (7 vertebrae) • Thoracic (12 vertebrae) • Lumbar (5 vertebrae) Below the lumbar spine is the sacrum which is composed of 5 fused vertebrae. At the end of the spine is the coccyx, or the tailbone. The vertebrae bear the weight of the upper body and provide points of attachment for muscles and ligaments and also feature bones called spinous processes. Spinous processes are the bones you can feel in the middle of your back if you run your hand over your spine. Vertebrae also protect the...

What is Degenerative Disc Disease? Degenerative changes in the spine may cause instability and pain in your back. Degenerative Disc Disease (DDD) involves the intervertebral disc and is part of the natural aging process. DDD can also result from torsional (twisting) injury to the lower back. In the normal spine, your discs act as a cushion between vertebrae. Over time the discs can lose flexibility, elasticity and height. When this happens, they lose their shock absorbing characteristics and can lead to abnormal motion or alignment of the spine, which may result in pain. Symptoms of DDD...

What is Spondylolisthesis? Spondylolisthesis is a condition in which one of the vertebrae slips forward or backward. If left untreated, this can lead to deformity of the spine and narrowing of the spinal canal. Typical symptoms include low back pain, muscle spasms, thigh or leg pain and weakness. Interestingly, some patients are asymptomatic and only learn of the disorder after spinal radiographs. Normal spine segment Displaced vertebra causing pressure on nerve SP-Fix™ Patient Information

Answers to your questions regarding SP-Fix Spinous Process Fixation System ™ How the SP-Fix™ Spinous Process Fixation System Works The SP-Fix™ Spinous Process Fixation System is a fixation device designed to provide supplemental fixation in your spine and supports a minimally invasive surgical technique. SP-Fix™ is available in various sizes to fit specific anatomy and comes in either a Plate and Barrel Assembly or a Plate Assembly. Your surgeon will recommend which procedure and implant is best for you and your condition. Plate and Barrel Assembly Plate Assembly

How is the Procedure Performed? Your surgeon may need to relieve excess pressure on the spinal cord or nerves. An incision will be made in your back over the affected area. Your surgeon will implant the device into your spine between your spinous processes. Once the device has been implanted, your surgeon will clamp the implant together, locking it to your spinous processes. Bone graft material is placed around the final assembly to facilitate fusion. SP-Fix™ is designed to be used with other fixation devices such as pedicle screws, facet screws or an interbody device with a plate and screw...

What Should I Expect with My Recovery? Treatment with SP-Fix™ Spinous Process Fixation System may help you return to normal activities. Many patients recover in 2–4 weeks; however, recovery time varies between patients. Some patients may be able to get out of bed the day of surgery and may be discharged the following day. A positive attitude, reasonable expectations and compliance with your doctor’s post-surgical instructions may all contribute to a satisfactory outcome. SP-Fix™ Patient Info

Contraindications, Complications, Warnings, and Precautions You may be contraindicated for this device if you have an infection, a congenital abnormality, are obese, pregnant, mentally ill, diabetic, suffer from rheumatoid arthritis, osteoporosis, or cancer. As with any surgical procedure, complications may occur following the placement of this device. These can include but are not limited to early or late implant bending, breakage, failure, loosening, movement/migration, bone fracture, and allergic reaction to implant material. Other general complications associated with any spinal...

Globus Medical Valley Forge Business Center 2560 General Armistead Avenue ©2011 Globus Medical. All rights reserved. Patents pending. Life moves us is a registered trademark of Globus Medical. SP-Fix is a trademark of Globus Medical. Caution: Federal (USA) Law Restricts this Device to Sale by or on the Order of a Physician. 8.11