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).
- 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.