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Prescription Information
Indication
The PhysioStim™ device is indicated for the treatment of an established nonunion
acquired secondary to trauma, excluding vertebrae and all flat bones, where the width
of the nonunion defect is less than one-half the width of the bone to be treated. A
nonunion is considered to be established when the fracture site shows no visibly
progressive signs of healing.
Contraindication
Use of this device is contraindicated where the individual has synovial pseudarthrosis.
Warnings
• The safety and effectiveness of the use of this device on individuals lacking skeletal
maturity has not been established.
• In the presence of a malaligned nonunion, careful consideration of the use of this
device must be undertaken on an individual basis, as treatment with this device is
not intended to alter or affect the degree of malalignment.
• Demand type pacemaker operation may be adversely affected by exposure to
pulsed electromagnetic fields. Physicians should not prescribe a PhysioStim device
for application which may place the treatment transducer in close proximity to the
pacemaker. Further screening by the attending cardiologist is recommended (such
as with an electrocardiogram).
• Animal studies conducted to date do not suggest any long-term adverse effects
from the use of this device. However, long-term effects in humans are unknown.
• The safety and effectiveness of this device on individuals with a nonunion
secondary to, or in connection with, a pathological condition has not been
established.
Precautions
• Nonunion fractures with gaps in excess of 1 centimeter (cm) have not been
evaluated.
• Although animal reproductive studies performed with this device demonstrated no
adverse findings, the safety of use of this device during pregnancy and nursing in
humans has not been established.
• This device should not be used if there are mental or physical conditions which
preclude patient compliance with physician and device instructions.
Adverse Events
Rare instances of reversible minor discomfort have been reported. They were:
cumbersome or uncomfortable, tingling or pain and minor skin rash.
Please refer to the Compliance Statements section of the manual for compatibility
information regarding implantable medical devices.
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