Safety Information

Who is a Candidate for the M6-L Artificial Lumbar Disc?

The M6-L™ artificial lumbar disc may be the right choice for you if the following statements are true:

  • You have pain, weakness, numbness or tingling in your lower back, legs or feet
  • Your doctor has diagnosed you with lumbar disc damage through MRI, CT or X-rays
  • Your doctor has diagnosed you with:
    • Degenerative disc disease
    • Ruptured or herniated disc
    • Bone spurs
    • Degeneration of the spine from wear and tear
  • You are 18 years or older
  • You have already tried physical therapy, chiropractic care, and/or medications for at least six months with unsuccessful results, or you have symptoms that your condition is worsening

If these statements are true, then you may be a candidate for the M6-L disc. Talk to your surgeon to determine if you are a candidate for the M6-L artificial lumbar disc.

NOTE: Approved indications for use, contraindications, warnings and precautions may vary among different regions/countries where the M6-L disc is distributed. Please consult your physician to determine if you are a candidate for the M6-L artificial lumbar disc.

Who is Not a Candidate for the M6-L Disc?

The M6-L artificial lumbar disc should not be implanted in patients with the following conditions:

  • Are older than 75 years old or younger than 18 years old
  • Have osteopenia or osteoporosis defined as a bone mineral density with T-score ≤-1.5 as determined by spine DXA if male older than 60 years of age or female older than 50 years of age
  • Have an active systemic infection or infection at the operative site
  • Have sustained an osteoporotic fracture of the spine, hip or wrist
  • Have received medications (e.g., methotrexate, alendronate) that interfere with bone and mineral metabolism within two weeks of the planned date of the index surgery
  • Have a history of endocrine or metabolic disorders (e.g., Paget’s disease) known to affect bone and mineral metabolism
  • Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV or active hepatitis
  • Prior intra-abdominal or retroperitoneal surgery that would make the approach prohibitively dangerous
  • Prior anterior surgery at the same level
  • Spinal metastases
  • Have a known allergy to titanium, polyurethane, polyethylene or ethylene oxide residuals
  • Have uncontrolled insulin dependent type 1 or type 2 diabetes
  • Require a treatment (e.g., posterior element decompression) that destabilizes the spine
  • Bony lumbar stenosis
  • Isolated radicular compression syndromes, especially due to disc herniation
  • Pars defect
  • Increased segmental instability
  • Spinal deformities, spondylolisthesis above 3mm at the involved level(s)
  • Radiological confirmation of severe facet joint disease or degeneration

What are the Warnings Associated with the M6-L Disc?

As with all surgeries there are potential risks. Speak with your doctor to learn more about risks specific to the M6-L artificial disc surgery. Correct placement of the M6-L disc is essential to achieving a desired outcome. The M6-L disc should only be used by surgeons who are experienced in the surgical procedure and have undergone adequate training with this device.

  • A lack of adequate surgeon experience and/or training may lead to a higher incidence of adverse events, such as vascular or neurological complications
  • X-rays must be taken during the surgical procedure. Failure to take appropriate x-rays during the M6-L disc surgery may result in patient injury
  • Advancement of the surgical instruments or the M6-L disc beyond the back border of the vertebral bodies may result in surgical complications

What Are the Precautions Associated with the M6-L Disc?

The safety and effectiveness of the M6-L artificial lumbar disc has not been established in patients with the following conditions:

  • Patients younger than 18 years old
  • More than one lumbar spine level or two adjacent levels requiring surgery other than adjacent levels between L3 and S1
  • Previous surgery at the spine level currently requiring surgery
  • Soreness of the back muscles as the only symptom
  • Prior surgery causing an unstable lumbar spine
  • Very limited forward/backward motion at the surgery level
  • Unstable spine at the surgery level or at the level above or below
  • Diseases of the bone that affect bone development or mineral levels
  • Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
  • Insulin-dependent diabetes
  • Extremely overweight patients (Body Mass Index > 30)
  • Additional precautions as described in the M6-L artificial lumbar disc Instructions For Use

Instructions For Use

Download the IFU for full information on instructions for use, contraindications, warnings, precautions, adverse reactions, and sterilization.

Download IFU

More Information on Lower Back Pain

Learn more about the M6-L procedure, its benefits, and recovery time.