Spinal Kinetics M6-L Mode D'emploi page 5

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The M6-L instruments are reusable, supplied non-sterile and must be sterilized in accordance
with the recommended cleaning and sterilization procedures. (See "Care And Handling
Instructions – Manual Surgical Instruments, PK 0234)
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Improper surgical use and technique may lead to suboptimal clinical outcomes.
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Postoperative rehabilitation and restrictions must be reviewed with the patient prior to discharge
from the hospital.
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The manufacturer is not responsible for any complications arising from incorrect diagnosis,
choice of incorrect M6-L, incorrect surgical techniques, including improper use of instruments,
the limitations of treatment methods, or inadequate asepsis.
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Excessive removal of subchondral bone during the preparation of the vertebral endplates may
lead to less than optimal clinical outcomes and is not recommended.
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The M6-L cannot be re-positioned in an anterior direction without complete removal. Take care
not to place the M6-L too posterior.
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Take care not to over-distract the disc space.
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Adequately instruct the patient on postoperative rehabilitation and limitations. Postoperative care
and the patient's ability and willingness to follow instructions are two of the most important aspects
of successful osseointegration of the implant. The patient must be made aware of the limitations of
the implant and that early strenuous physical activity and high load bearing have been implicated in
premature loosening of fixation prior to proper integration. An active, debilitated, or uncooperative
patient who cannot properly restrict activities may be at particular risk during postoperative
rehabilitation.
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Physicians should instruct patients to contact surgeon in the event of significant increase in pain
which may indicate a device performance issue.
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The M6-L Artificial Disc has not been evaluated for safety and compatibility in the MR
environment. It has not been tested for heating or migration in the MR environment.
Potential Risks and Adverse Events
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Adverse/allergic reaction to implant materials
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M6-L migration in the anterior-posterior direction
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M6-L subsidence requiring subsequent surgical intervention
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Placement difficulties requiring acute implant removal
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Excessive facet loading
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Kyphosis or hyper-extension
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Loss of flexibility
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Asymmetric range of motion
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Spondylotic bridging
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Vertebral body fracture
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Infection
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Spinal cord damage
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Neurologic damage or failure to relieve symptoms
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Implant failure
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M6-L wear, fatigue or fracture
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M6-L instability leading to unstable movement of the spine
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Separation of M6-L components
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Excessive M6-L height loss requiring subsequent surgical intervention
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Wear debris
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Material degradation
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Risks associated with general and spine surgery include:
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Excessive bleeding
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Anesthesia reaction
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Respiratory disorders
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Heart attack
EN
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