Prescription Information; Indication; Contraindication; Warnings - Orthofix CervicalStim 5505CM Manuel D'instructions

Prescription Information

Indication

The CervicalStim device is a noninvasive, pulsed electromagnetic bone growth
stimulator indicated as an adjunct to cervical fusion surgery in patients at
high-risk for non-fusion.

Contraindication

There are no known contraindications for the CervicalStim device as an
adjunct to cervical spine fusion surgery.

Warnings

• Do not use the CervicalStim device if you have a cardiac pacemaker
or defibrillator because it may interfere with the operation of your
pacemaker or defibrillator. If you use the CervicalStim device and it affects
your pacemaker or defibrillator, it may injure your heart. Consult your
cardiologist before using the CervicalStim device.
• Remove the CervicalStim device prior to any imaging procedures (e.g.,
CT scan, MRI, etc.). If you wear the CervicalStim device during these
procedures, you could be injured, the imaging being produced may be
ruined, and/or the CervicalStim device could be damaged.

Precautions

• Avoid using the CervicalStim device if you do not understand the
instructions your doctor has given you. If you use the CervicalStim device
incorrectly, it may harm you or may not help your healing process.
• The CervicalStim device 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 Summary

Adverse effects may be experienced when using the CervicalStim device. 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 CervicalStim device. Any adverse effects that are related to the
CervicalStim device should stop when you discontinue use.
See the Adverse Events Table for a list of all adverse events reported during
the clinical study.
Please refer to the Compliance Statements section of the manual for
compatibility information regarding implantable medical devices.
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