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CAUTION:
Excessive removal of subchondral bone during the preparation of the vertebral endplates may
lead to less than optimal clinical outcomes and is not recommended.
Once removed from the package, keep the M6 cervical disc from coming into contact with
any cloth, sponges or other foreign material that may become attached to the Titanium
Plasma Spray Coating of the endplates. The Package Clip may be used to safely store the
loaded M6 cervical disc.
The M6 cervical disc cannot be re-positioned in an anterior direction without complete
removal. Take care not to place the M6 cervical disc too posterior.
Take care not to over-distract the disc space.
Potential Risks and Adverse Events
•
Adverse/allergic reaction to implant materials
•
M6 cervical disc migration in the anterior-posterior direction
•
M6 cervical disc subsidence requiring subsequent surgical intervention
•
Placement difficulties requiring acute implant removal
•
Excessive facet loading
•
Kyphosis or hyper-extension
•
Loss of flexibility
•
Asymmetric range of motion
•
Spondylotic bridging
•
Vertebral body fracture
•
Infection
•
Spinal cord damage
•
Neurologic damage or failure to relieve symptoms
•
Ankylosis
•
Heterotopic ossification
•
Implant failure
-
M6 cervical disc wear, fatigue or fracture
-
M6 cervical disc instability leading to unstable movement of the spine
-
Separation of M6 cervical disc components
-
Excessive M6 cervical disc height loss requiring subsequent surgical intervention
-
Wear debris
-
Material degradation
•
Risks associated with general and spine surgery include:
-
Excessive bleeding
-
Anesthesia reaction
-
Respiratory disorders
-
Heart attack
-
Nerve or spinal cord damage leading to sensory loss
-
Pneumonia
-
Blood mass/clot
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