Orthofix M6-C Artificial Cervical Disc Gebrauchsanweisung Seite 5

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The M6‑C Manual Surgical 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.
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During implantation, the surgeon should ensure that none of the surgical instruments or the M6‑C Artificial Cervical Disc
progress beyond the posterior border of the vertebral bodies. Due to the proximity of vascular and neurological structures
to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurological damage with the use of
this device and allowing the instruments or the M6‑C Artificial Cervical Disc to progress beyond the posterior border of the
vertebrae may result in injury to these structures.
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Fluoroscopic confirmation of positioning of certain instruments and the implant should be performed during the surgical
procedure. Failure to confirm position of instruments and the implant during the surgical implantation procedure may result
in patient injury.
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Ensure that the appropriate size M6‑C Artificial Cervical Disc is chosen. Using an inappropriately sized M6‑C Artificial Cervical
Disc may result in less than optimal clinical outcomes. Proper sizing should be determined in accordance with the M6‑C
Artificial Cervical Disc Operative Technique Manual.
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Use of the M6‑C Artificial Cervical Disc at an index level where the planned treatment also involves a long hybrid, or a multi‑
hybrid, construct may lead to hyper‑physiologic loading conditions, increased wear, and premature failure.
c
aUtIons
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Perform a complete discectomy of the disc space between the uncinates and up to the posterior ligament. Take care to release
/ decompress the foramen bilaterally.
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It is important to remove all anterior and posterior osteophytes on the superior and inferior vertebral endplates. To prevent
weakening of the endplates, use of a burr/drill is discouraged during endplate preparation. Use the Cervical Retainer as
needed to maintain distraction. Take care not to over‑distract the disc space. Ensure proper alignment and placement of the
device as misalignment may cause excessive wear and/or early failure of the device.
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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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Once removed from the package, keep the M6‑C Artificial 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 Packaging Clip
may be used to safely store the loaded M6‑C Artificial Cervical Disc.
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The M6‑C Artificial Cervical Disc is designed to be implanted with the endplates parallel to each other. Excessive endplate
lordosis or kyphosis can lead to less than optimal M6‑C Artificial Cervical Disc performance.
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The M6‑C Artificial Cervical Disc cannot be re‑positioned in an anterior direction without complete removal. Take care not to
place the M6‑C Artificial Cervical Disc too posterior.
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Surgical implants must never be re‑used or re‑implanted. Even though the device appears undamaged, it may have small
defects and internal stress patterns that may lead to early breakage.
p a e
otentIal dverse ffects
Below is a list of the potential adverse effects (e.g., complications) identified for: (1) those associated with any general surgical
procedure; (2) those associated with anterior cervical spine surgery; and (3) those associated with a cervical artificial disc device,
including the M6‑C Artificial Cervical Disc. In addition to the risks listed below, there is also the risk that surgery may not be
effective in relieving symptoms, or may cause worsening of symptoms. Additional surgery may be required to correct some of
the adverse effects.
General Surgery Risks
General surgical risks are, but may not be limited to:
• Infection/abscess/cyst, localized or systemic
• Blood clots, including pulmonary emboli
• Medication and anesthesia reactions
• Phlebiti
• Pneumonia
• Atelectasis
• Soft tissue damage
• Septicemia
• Hemorrhage possibly requiring a blood transfusion, with possible
transfusion reaction
• Myocardial infarction
• Paralysis
• Poor tissue healing
• Cerebrovascular accident (CVA)
• Death
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