Safety Statement

Simplify Disc Cervical Artificial Disc

Indications: Simplify Disc is indicated for use in skeletally mature patients for reconstruction of the disc at 1 level from C3-C7 following single-level discectomy for radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and manifested by at least 1 of the following conditions confirmed by radiographic imaging: herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. Patients receiving Simplify Disc should have failed at least 6 weeks of non-operative treatment or have the presence of progressive symptoms prior to implantation.

Warnings: Simplify Disc should only be used by experienced surgeons who have been trained in the use of Simplify Disc, including instruction in correct implant sizing for proper function. Removal of the Simplify Disc may damage the disc, so a new disc should be used. There are risks of serious or fatal hemorrhage and risks of neurological damage and/or injury to adjacent organs with the use of Simplify Disc. There is a risk of heterotopic ossification at either the treated level or adjacent levels.

Side Effects: 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 Radiculopathy, Spasm, Inflammation, Infection, Pain, Dysphagia, , Numbness, Adjacent Segment Degeneration, and Headache.. The surgical procedure may not be effective, and may not relieve or may cause worsening of pre-operative symptoms. There may be a need for additional surgery.

Contraindications Active infection; Intractable radiculopathy or myelopathy necessitating surgical treatment at more than one cervical level; Osteoporosis/osteopenia defined as DEXA bone mineral density T-score worse than -1.5; Known allergy to PEEK, ceramic, or titanium; Severe facet disease or facet degeneration; Bridging osteophytes; Marked cervical instability; and Significant cervical anatomical deformity at the index level or compromised cervical vertebral bodies at the index level due to trauma or diseases, such as rheumatoid arthritis.

For full safety information refer to ifu.simplifymedical.com Simplify Disc Instructions for Use, Summary of Safety and Effectiveness and Surgical Technique Guide.