2
C. Contraindications, General Warnings
and Precautions
Contraindications:
There are no known contraindications to the use of
this device.
Nonunion Indication:
Warnings:
The safety and effectiveness of the use of this device has
not been established in nonunions for the following:
•
nonunions of the vertebra and the skull.
•
individuals lacking skeletal maturity.
Precautions:
•
The safety and effectiveness of the use of this device in
pregnant or nursing women has not been established.
•
Careful consideration of the use of this device must be
decided on an individual basis in the presence of
malaligned nonunion since the device will not correct or
alter displacement, angulation or other malalignment.
•
Cell phones may cause interference and patients should
avoid cell phone use during treatments.
•
With active, implantable devices, such as cardiac
pacemakers, operation may be adversely affected by close
exposure to the EXOGEN™ device; therefore, evaluation
during EXOGEN treatment by the attending cardiologist or
physician is recommended.
•
Patients in the clinical studies were instructed to apply the
device for one treatment period of 20 minutes each day.
The safety and effectiveness of the EXOGEN device when
used for more than one daily 20-minute treatment period
is unknown.
•
The age ranges of the patients in the PMA nonunion
studies were 17–86. The effect of EXOGEN therapy on
patients outside this age range is unknown.
Complications:
No device-related adverse reactions or medical
complications related to the use of this device were
reported during the clinical studies. Two patients in a post-
market registry reported mild skin irritation caused by skin
sensitivity to the coupling gel. Both were resolved by a
change of coupling medium to mineral oil or glycerin.
