INDICATIONS: The Biomet® SpinalPak®
Non-invasive Spine Fusion Stimulator System is a noninvasive spine
fusion stimulator indicated as an adjunct electrical treatment to
primary lumbar spinal fusion surgery for one or two levels – (P850022/S017).
USAGE: The SpinalPak Non-invasive Spine Fusion Stimulator
System is designed to deliver 270 days of continuous therapeutic
treatment for 24 hours per day. The recommended daily therapeutic
treatment is continuous for 24 hours. Federal Law (U.S.A.) restricts
this device to sale by or on the order of a physician. Rx Only -
Prescription Only - Single Patient Use Only - Not for Re-Sale or
Re-Distribution - Do Not Reuse.
CONTRAINDICATIONS: There are no known contraindications
regarding the use of the Biomet® SpinalPak®
Spine Fusion Stimulator System.
WARNINGS: The concomitant use of the device and a pacemaker or
cardioverter must be assessed on an individual basis, such as with an
electrocardiogram, prior to use. The patient should be referred to a
cardiologist for monitoring of pacemaker function while wearing the
active Biomet® SpinalPak® Non-invasive Spine
Fusion Stimulator System device. If there are any observable adverse
changes in the pacemaker rhythm or output, the device should not be used.
The safety and effectiveness of the Biomet®
SpinalPak® Non-invasive Spine Fusion Stimulator System in
pregnant women have not been studied, and the effects of the device on
the mother or the developing fetus are unknown. A patient who is
either pregnant or is intending to become pregnant should be referred
to her doctor prior to treatment with the device.
PRECAUTIONS: The Biomet® SpinalPak®
Non-invasive Spine Fusion Stimulator System has not been studied in
individuals with the following conditions: spondylitis, infection,
Paget’s disease, cancer, diabetes mellitus, renal disease, trauma of
the lumbar spine and osteoporosis: therefore, the safety and
effectiveness of the device in these individuals is unknown.
Complete prescribing information including warnings and precautions
associated with the use of this device may be found online at www.LearnAboutBoneHealing.com
or by contacting customer service at 1-800-526-2579, extension 6000.
If you have additional questions regarding your doctor’s
instructions in using this device, or you are experiencing any type of
adverse reaction with the use of this device, contact your doctor
immediately. For further product information, including warnings,
refer to the Patient Manual at www.LearnAboutBoneHealing.com,
or contact Customer Service at 1-800-526-2579, extension 6000.