Prescription Information - Orthofix SPINAL-Stim Manual De Instrucciones

Prescription Information

Indication
The Spinal-Stim is a noninvasive electromagnetic bone growth stimulator
®
indicated as a spinal fusion adjunct to increase the probability of fusion success
and as a nonoperative treatment of salvage of failed spinal fusion, where a
minimum of nine months has elapsed since the last surgery.
Contraindication
Cardiac pacemakers may be adversely affected by exposure to PEMF.
Use of this device is contraindicated where the individual has an implanted
cardiac pacemaker.
Warnings
• Although animal teratological studies performed with the device
demonstrated no adverse findings, the safety of use of this device during
pregnancy and nursing in humans has not been established.
• The safety and effectiveness of the use of this device on individuals lacking
skeletal maturity have not been established.
• Animal studies conducted to date do not suggest any long-term adverse
effects from the use of a similar device. However, long-term effects in
humans are unknown.
Precautions
• This device should not be used if there are mental or physical conditions
which preclude compliance with the physician and device instructions.
• This 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,
and uncontrolled diabetes mellitus.
• The results of premarketing data from the randomized double-masked
cohort indicate that inconsistent users (defined as those patients that used
the device for less than an average of two hours per day) had success rates
similar to those in the placebo group. Therefore, the use of the device
for less than the minimum recommended usage may result in lower
success rates.
Adverse Events
Rare instances of reversible minor discomfort have been reported.
They were: cumbersome or uncomfortable, minor tingling or pain,
minor skin rash, insomnia, fainting, nausea/diarrhea, and polymenorrhea.
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