Contraindications

The coflex® is contraindicated in patients with:

  • Prior fusion or decompressive laminectomy at any index lumbar level.
  • Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
  • Severe facet hypertrophy that requires extensive bone removal which would cause instability.
  • Grade II or greater spondylolisthesis.
  • Isthmic spondylolisthesis or spondylolysis (pars fracture).
  • Degenerative lumbar scoliosis (Cobb angle of greater than 25º).
  • Osteoporosis.
  • Back or leg pain of unknown etiology.
  • Axial back pain only, with no leg, buttock, or groin pain.
  • Morbid obesity defined as a body mass index > 40.
  • Active or chronic infection – systemic or local.
  • Known allergy to titanium alloys or MR contrasting agents.
  • Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction.

 

FDA PMA P110008, October 2012. All data on file at Paradigm Spine, LLC.