Orthofix M6-C Artificial Cervical Disc Gebrauchsanweisung Seite 4

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The M6‑C Artificial Cervical Disc System is intended to be used only by surgeons with training in cervical spine surgery and
related surgical techniques, and biomechanical principles of the spine and spine arthroplasty.
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Prior to use, the surgeon must be trained in the surgical procedure as outlined in the M6‑C Artificial Cervical Disc Operative
Technique Manual and thoroughly familiar with the implant and instruments.
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Improper surgical use and technique may lead to suboptimal clinical outcomes.
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Do not use the M6‑C Artificial Cervical Disc 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‑C Artificial Cervical Disc to ensure it
exhibits no signs of damage (e.g., metal and plastic damage).
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The M6‑C Artificial Cervical Disc must be implanted using the M6‑C Manual Surgical Instruments. 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‑C Artificial 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‑C Artificial 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‑C Artificial
Cervical Disc, incorrect surgical techniques, including improper use of instruments, the limitations of treatment methods, or
inadequate asepsis.
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The surgeon should 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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Instructions for postoperative care should be according to the surgeon's discretion and may consist of a physician‑managed,
individual post‑operative rehabilitation program. Certain activities should be limited or avoided for two weeks postoperative.
It is recommended that the surgeon discuss with the patient the following limitations:
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Excessive neck movements: Short term use of a soft neck collar to stabilize the neck and reduce excess movement is an
option. Instruct patient to avoid excessive flexion/extension for two weeks postoperative.
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Heavy lifting: Avoid lifting anything heavier than about 3.5‑4.5 kilograms (8‑10 pounds) for two weeks postoperative.
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Returning to work: In general, return to light work, such as a desk job or school, approximately one week after surgery.
Returning to a more physical job, such as construction, may take six weeks or longer.
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Resuming sports and other physical activities: The timeline for returning to sports and other recreational activities can
vary. The weight permitted for lifting may gradually increase starting after two weeks. Some light sport activities may be
permitted at about 4 weeks, such as jogging, biking, or swimming. A return to competitive sports may take 6 weeks or
longer, depending on the integration of the device and the ability to perform the sport's movements pain‑free. There is
currently a lack of data regarding cervical artificial discs and contact or extreme sports.
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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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Routine long term clinical and radiographic monitoring of patients implanted with the M6‑C is suggested to assess any
changes in implant condition or surrounding anatomy. Changes in disc position, loss of height and peri‑prosthetic bone loss
may be indicative of onset of osteolysis. Peri‑prosthetic osteolysis may result in neck pain and serious neurological sequelae
including cervical spinal cord compression and quadriplegia.
W
arnIngs
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Correct placement of the M6‑C Artificial Cervical Disc is essential to optimal performance.
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The M6‑C Artificial Cervical Disc should only be used by surgeons who are experienced in the surgical procedure and have
undergone adequate training with this device. A lack of adequate experience and/or training may lead to a higher incidence of
adverse events, such as vascular or neurological complications.
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The M6‑C Artificial Cervical Disc is single use only. Do not re‑sterilize or reuse the M6‑C Artificial Cervical Disc. Re‑sterilizing
and/or reusing the M6‑C Artificial Cervical Disc may result in impaired performance and could cause patient injury and/or the
communication of infectious diseases between patients.
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