Contraindications - Spinal Kinetics M6-L Mode D'emploi

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Contraindications

The M6-L should not be implanted in patients with the following conditions:
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Be >75 years of age, or < 18 years of age
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Osteopenia or osteoporosis defined as a bone mineral density with T-score ≤-1.5 as determined
by spine DXA if male ≥60 years of age or female ≥50 years of age
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Have an active systemic infection or infection at the operative site
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Have sustained an osteoporotic fracture of the spine, hip or wrist
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Have received medications (e.g. methotrexate, alendronate) that interfere with bone and mineral
metabolism within 2 weeks of the planned date of the index surgery
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Have a history of endocrine or metabolic disorders (e.g., Paget's disease) known to affect bone
and mineral metabolism
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Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV or
active hepatitis
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Prior intra-abdominal or retroperitoneal surgery that would make the approach prohibitively
dangerous
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Prior anterior surgery at the same level
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Spinal metastases
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Have a known allergy to titanium, polyurethane, polyethylene or ethylene oxide residuals.
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Have uncontrolled insulin dependent type 1 or type 2 diabetes
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Require a treatment (e.g., posterior element decompression) that destabilizes the spine.
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Bony lumbar stenosis
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Isolated radicular compression syndromes, especially due to disc herniation
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Pars defect
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Increased segmental instability
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Spinal deformities, spondylolisthesis above 3mm at the involved level
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Radiological confirmation of severe facet joint disease or degeneration
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Clinically compromised vertebral body structure (unhealed fracture) due to acute or past trauma at the
level to be treated or an adjacent level, or endplate incompetence
•
Abuse of pharmaceuticals, alcohol, or other substances
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BMI above 30
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Pregnancy
Precautions
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Read and understand the M6-L Artificial Lumbar Disc System Instructions for Use prior to use.
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Correct placement of the device is essential to optimal performance. Use of the M6-L Total Disc
Replacement should only be undertaken after the surgeon has become thoroughly knowledgeable
about spinal anatomy and biomechanics; has had experience with anterior approach spinal
surgeries; and has had hands-on training in the use of this device.
•
The trial, chiseling, and insertion steps for the device must be performed under fluoroscopic
visualization. Extreme care must be taken to avoid placing the device or any instrument beyond
the posterior edge of either vertebral body. The user must maintain control and visual reference via
fluoroscopy. Failure to visualize the trial, chiseling, and insertion steps could result in patient injury.
•
Ensure that the appropriate size M6-L is chosen. Using an inappropriately sized M6-L may result
in less than optimal clinical outcomes. Proper sizing should be determined in accordance with the
Spinal Kinetics M6-L Artificial Lumbar Disc Surgical Technique Manual.
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The M6-L must be implanted using the Spinal Kinetics lumbar instrumentation only. The use of the
Spinal Kinetics instruments for purposes other than those for which they are intended may result
in damaged or broken instruments. Do not use any other implant components or instrumentation.
Refer to the Spinal Kinetics M6-L Artificial Lumbar Disc Surgical Technique Manual for
implantation instructions.
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