Safety and Efficacy of the CarboFix Pedicle Screw System

Inclusion criteria

• Subject is 18 years old or older.
• Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
• Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
• Informed consent given by the subject.

Exclusion criteria

• Subject is not eligible for fixation with market-available fixation means.
• Familial history NF2.
• Acute traumatic spinal injury with or without neurological signs.
• Metabolic bone disease.
• History of Paget's disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
• History of mental disorder or current psychiatric treatment.
• Pregnancy and/or female subjects intending to become pregnant within the expected time frame of the study and/or female subjects of child bearing age who do not use conventional contraceptive methods.
• Immune deficiency disease.
• Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests).
• Scoliosis.
• Treatment with drugs that may interfere with bone metabolism such as:

• Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.
• Calcitonin within the past 6 months.
• Bisphosphonates for 30 days or more within the last 12 months.
• Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.
• Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.
• Treatment by chemotherapy within the last 12 months.
• Lack of willingness to make a commitment to return for required follow up visits.
• Drug and/or alcohol abuse.
• Morbid obesity.
• Metal allergies.
• Recent use of other investigational drugs or devices (within the past 30 days).