There is always potential risk in having surgery or getting a medical device implanted. Usually these risks are rare. You should refer to the Coflex® Patient Labeling for a list of all potential risks and hazards that were observed during the clinical study. For patients receiving the Coflex® device, the biggest risk is continued pain. Other risks include wound healing problems (such as infection or drainage), brief numbness or tingling in your arms or legs, and spinous process fractures. Some patients had illnesses or diseases not related to their surgery, like problems with their skin, problems breathing, problems with their heart, and other muscle or bone pain or soreness. In the clinical trial, similar problems were experienced with patients who had fusion. The Coflex® device may not help relieve pain in some patients, and you may need another surgery to remove the device. It is hard to predict who will not benefit from this surgery. Although uncommon, the device could be removed if necessary.
The Coflex® device 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
Non-clinical testing has shown that the Coflex® Interlaminar Stabilization® 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.