Prescription Information; Adverse Effects - Orthofix Cervical-Stim 2505 Patient Manual

Prescription Information

Indication
The Cervical-Stim
stimulator indicated as an adjunct to cervical fusion surgery in patients at
high-risk for non-fusion.
Contraindications
There are no known contraindications for the Cervical-Stim as an adjunct
to cervical spine fusion surgery.
Warnings
• Do not use Cervical-Stim if you have a cardiac pacemaker or defibrillator
because it may interfere with the operation of your pacemaker or
defibrillator. If you use the Cervical-Stim and it affects your pacemaker
or defibrillator, it may injure your heart. Consult your cardiologist.
• Remove the Cervical-Stim prior to any imaging procedures (e.g., CT scan,
MRI, etc.). If you wear the Cervical-Stim during these procedures, you
could be injured, the imaging being produced may be ruined, and/or the
Cervical-Stim could be damaged.
Precautions
• Avoid using the Cervical-Stim if you do not understand the instructions your
doctor has given you. If you use the Cervical-Stim incorrectly, it may harm
you or may not help your healing process.
• The Cervical-Stim has not been evaluated in treating patients with the
following conditions: osseous or ligamentous spinal trauma, spondylitis,
Paget's disease, moderate to severe osteoporosis, metastatic cancer, renal
disease, rheumatoid arthritis, uncontrolled diabetes mellitus, patients prone
to vascular migraine headache, seizure, epilepsy, thyroid conditions or
neurological diseases.
• Animal reproductive studies performed with this device did not show any
harmful effects in animals. However, the safety of this device for use on
patients who are pregnant or nursing has not been established.

Adverse Effects

Adverse effects may be experienced when using the Cervical-Stim. These
adverse effects may include: increased pain, numbness and tingling, headache,
migraines and nausea. These effects may or may not be directly related to
use of the Cervical-Stim. Any adverse effects that are related to the
Cervical-Stim should stop when you discontinue use. The following table
shows all adverse events that were reported during the clinical study.
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is a noninvasive, pulsed electromagnetic bone growth
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