Spinal Kinetics M6-C Mode D'emploi page 6

EN
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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 cervical
disc to ensure it exhibits no signs of damage (e.g., metal and plastic damage).
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The M6 cervical disc must be implanted using the M6 cervical disc instrumentation. 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.
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Detailed instructions on the use and limitations of the M6 cervical disc must be given to the patient.
Postoperative rehabilitation and restrictions must be reviewed with the patient prior to discharge
from the hospital.
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The M6 cervical disc serial number and the size must be documented for each patient record.
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The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice
of incorrect M6 cervical disc, incorrect surgical techniques, including improper use of instruments,
the limitations of treatment methods, or inadequate asepsis.
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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-C 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.
WARNING:
Failure to read and follow the Instructions for Use and the instructions in the M6 artificial
cervical disc Surgical Technique Manual may result in patient injury or death.
The M6 cervical disc is single use only. Do not re-sterilize or reuse the M6 cervical disc.
Re-sterilizing and/or reusing the M6 cervical disc may result in impaired performance and
could cause patient injury and/or the communication of infectious diseases between patients.
The M6 artificial cervical disc instruments are reusable, supplied non-sterile and must be
sterilized in accordance with the recommended cleaning and sterilization procedures
contained within the individual instrument Instructions for Use booklet.
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 artificial cervical disc is chosen. Using an inappropriately
sized M6 cervical disc may result in less than optimal clinical outcomes. Proper sizing should
be determined in accordance with the M6 artificial cervical disc Surgical Technique Manual.
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