Patient Safety Statement

Simplify® Disc Cervical Artificial Disc

Indications

The Simplify Disc is an artificial disc used for disc replacement, from C3-C7. The disc is used in patients with cervical disc degeneration at one disc space. This degeneration may cause pain, numbness, or tingling. A doctor may recommend Simplify Disc surgery based on your symptoms as confirmed by X-rays, CT and/or MRI. Your doctor will tell you if you are a candidate for this procedure. You will likely be treated non-surgically first. This often includes rest, physical therapy, and injections.

Warnings

Simplify Disc should only be used by experienced surgeons who have been trained in the use of Simplify Disc. The use of Simplify Disc may cause serious or fatal bleeding and risks of neurological damage and/or injury to nearby organs. There is a risk of extra bone growth which could lead to reduced cervical motion or fusion.

Risks

Potential risks associated with the use of Simplify Disc include, but are not limited to, those commonly associated with surgery, specific to anterior cervical surgery, and spinal implants, as well as Simplify Disc including Arm pain, Numbness, Weakness and Tingling; Spasm; Inflammation; Infection; Pain; Difficulty swallowing; Adjacent Segment Degeneration, and; Headache. The surgical procedure may not be effective, and may not relieve or may cause worsening of symptoms. There may be a need for additional surgery.

Who Should Not Receive the Simplify Disc

Simplify Disc should not be implanted in patients with the following conditions: Active infection; Degenerative disc symptoms necessitating surgical treatment at more than one cervical level; Osteoporosis/osteopenia; Known allergy to implant materials including PEEK, ceramic or titanium; Severe facet disease or facet degeneration; Bridging bone between bones in the spine; Cervical spine instability as shown by X-ray; and Significant spine deformity at the location of the surgery, and diseases affecting the spine such as rheumatoid arthritis or spondylitis.

Always talk to your doctor with questions about your neck pain and treatment options. For additional safety information refer to ifu.simplifymedical.com.