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 - OUS Dounload IFU - Canada

More Information on Lower Back Pain

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