Usage; Adverse Effects - BIOMET EBI Bone Healing System Patient Manual

Indications, Contraindications, Usage and Adverse Effects
(Continued)

Usage:

This Bone Healing System is a durable therapeutic electrical medical
device intended for single patient use only under a prescription.
Federal Law (U.S.A.) restricts this device to sale by or on the order
of a physician. Rx Only - Prescription Only - Single Use Only -
Not for Re-Sale or Re-Distribution - Do Not Reuse.

Adverse Effects:

The original EBI Bone Healing System was approved and introduced
®
in 1979. Since then, over 600,000 systems have been marketed. The
safe and effective use of non-invasive bone growth stimulation devices
over this time has clearly established their therapeutic benefit of use.
In addition, all known hazards associated with the use of Bone Healing
Systems do not present an unreasonable risk of illness or injury when
compared to their therapeutic benefit and can be typically addressed by
either modifying or terminating treatment.
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