Performance of the Hedrocel(R) Cervical Fusion Device

Exclusion Criteria

• •The patient is mentally compromised (e.g., under treatment for a psychiatric disorder or has senile dementia or Alzheimer's disease), or has evidence of alcohol or other substance abuse for the previous 12 months.
• •The patient has a neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
• •The patient has a diagnosed systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory and steroidal drugs.
• •The patient has osteopenia to a degree that would contraindicate spinal instrumentation (borderline osteoporosis).
• •The patient has osteoporosis to a degree that would contraindicate spinal instrumentation.
• •The patient is unable or unwilling to attend postoperative follow-up visits.
• •The patient has received an investigational drug within the previous six months or an investigational device within the previous 12 months.
• •The patient has a spinal condition other than Cervical DDD based upon physical examination and medical history.
• •The patient has an infection site distant from the involved levels that may spread to the involved levels hematogenously.
• •The patient has insufficient bone stock to fix the component.
• •The patient has a known sensitivity to metallic implants.
• •The patient is a prisoner.
• •The patient has a Body Mass Index (BMI) greater than or equal to 40.