IMPORTANT SAFETY INFORMATION SCOLIOSIS SURGERY

RISKS OF SPINAL SURGERY

All treatment and outcome results are specific to the individual patient. Results may vary. Complications such as infection, nerve damage, blood loss, and bowel and bladder problems are some of the potential risks of any type of spinal surgery, including spinal fusion for the treatment of scoliosis.

Additional complications that may be associated with scoliosis surgery include loss of proper spinal balance, failure of the bones to properly heal and fuse (pseudoarthrosis), instrumentation failure, and vertebral degeneration in the levels adjacent to the fused section.

Please consult your doctor for a complete list of indications, warnings, precautions, adverse effects, clinical results, and other important medical information that pertains to scoliosis surgery.

RISKS OF CD HORIZON IMPLANTS AND INSTRUMENTATION

Potential risks associated with a posterior approach to scoliosis surgery and the instrumentation used to perform the procedure include but are not limited to:

  • Tissue or nerve damage caused by improper positioning and placement of implants or instruments
  • Disassembly, bending, and/or breakage of any or all of the components
  • Nonunion (or pseudarthrosis), delayed union, or mal-union
  • Postoperative change in spinal curvature, loss or correction, height, and/or reduction
  • Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant, possibly causing skin penetration, irritation, internal scaring, tissue death, and/or pain

CD HORIZON INDICATIONS

The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD -defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.