How Supplied - Spinal Kinetics M6-L Mode D'emploi

EN
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Nerve or spinal cord damage leading to sensory loss
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Pneumonia
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Blood mass/clot
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Side effects from medicine used during and after surgery
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Scarring of the spinal canal sheath
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Bruising
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Damage to blood vessels near spine
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Opening of the wound
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Loss of fluid surrounding the spinal cord
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Stroke
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Superficial or deep wound infection
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Accumulation of fluid within the incision
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Additional surgery
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Incorrect treatment level
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Ongoing pain
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Spinal fractures
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Ankylosis
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Heterotopic ossification

How Supplied

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The M6-L lumbar disc is supplied sterile and is single use only. Do not re-sterilize or reuse the M6-L.
Re-sterilizing and/or reusing the M6-L may result in impaired performance and could cause patient
injury and/or the communication of infectious diseases between patients.
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Do not use the M6-L after the last day of the month of the "Use by date" on the label.
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Inspect the device package before opening. Do not use if package is damaged or shows any evidence
of breached packaging, compromised device sterility, or storage above 60 °C (140 °F).
The temperature recorder label on the box turns black if the product has reached 60˚C (140˚F).
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Use sterile technique to carefully remove the disc from the packaging. Inspect the M6-L to ensure it
exhibits no signs of damage (e.g., metal and plastic damage).
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Once removed from the package, keep the M6-L 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.
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The M6-L serial number and the size must be documented for each patient record.
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The M6-L lumbar disc has not been evaluated for safety and compatibility in the magnetic resonance
(MR) environment and has not been tested for heating or migration in the MR environment.
Device Retrieval
Should it be necessary to remove a M6-L Artificial Disc, please contact Spinal Kinetics to receive
instructions regarding the data collection, including histopathological, mechanical, and adverse
event information. Please refer to the M6-L Surgical Technique Manual for step by step instructions
on the required surgical technique for device retrieval. All explanted devices must be returned to
Spinal Kinetics for analysis.
Please note that the artificial disc should be retrieved as carefully as possible in order to keep the
Implant and surrounding tissue intact. Also please provide descriptive information about the gross
appearance of the device in situ, as well as descriptions of the removal methods, e.g. intact or in pieces.
Spinal Kinetics, Inc. warrants that reasonable care has been used in the manufacture of this device.
There are no express or implied warranties, including fitness for a particular purpose, for this M6-L
System. Any description or specifications provided are solely to describe the product at the time of
manufacture and do not constitute any express or implied warranties. Spinal Kinetics, Inc. is not
responsible for any direct, incidental, special, or consequential loss, damage, or expense based on
any defect, failure, or malfunction of this product, other than as expressly provided by mandatory
provisions of applicable law. No person has the authority to bind Spinal Kinetics, Inc. to any
representation or warranty except as provided in this Limited Warranty.
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Limited Warranty