US Specific Contraindications

The coflex® implant 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

  • For complete contraindication information, please download the coflex® implant Contraindications Card (PDF).

MRI Safety for US Only

Non-clinical testing has shown that the coflex® implant is MR conditional and can be scanned safely under the following conditions.

  • Static magnetic field of 1.5-Tesla (1.5T) or 3.0-Tesla (3.0T).
  • Spatial gradient field of up to:
    • 11,230 G/cm (112.3 T/m) for 1.5T systems
    • 5,610 G/cm (56.1 T/m) for 3.0T systems
  • Maximum whole body averaged specific absorption rate (SAR) of:
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5T
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0T

To learn more about MRI compatibility review our full list of specifications.

For additional safety information and support, contact Companion Spine.