Indications, Contraindications, Usage And Adverse Effects; Indications; Contraindications - BIOMET EBI Bone Healing System Patient Manual

Indications, Contraindications, Usage and Adverse Effects

Indications:

1. The Biomet
treatment of fracture nonunions, failed fusions, and congenital
pseudarthrosis in the appendicular system. A nonunion
is considered to be established when there are no visibly
progressive signs of healing.

Contraindications:

1. Under certain conditions, electromagnetic stimulation
generated by a bone healing system could inhibit the output
of some demand pacemakers or implantable defibrillators.
Therefore, it is not recommended for patients with certain
types of pacemakers or implantable defibrillators. Patients
should be cautioned to avoid coming in close proximity
to pacemaker or defibrillator wearers during stimulation
treatment. The use of bone healing systems on pregnant
patients has not been evaluated; therefore, it is not
recommended in these cases. The long term effects of
exposure to low level magnetic fields created by bone healing
systems are not known.
2. Nonunion fractures in which a synovial pseudarthrosis (fluid
filled gap exists).
3. Use of the Biomet
patients has not been evaluated; therefore, it is not
recommended in these cases.
4. The Biomet
safety or been evaluated for heating in the MR environment.
The effects of MRI procedures and scans using MR systems
has not been determined or established" therefore, MRI scans
and procedures should not be performed on patients until the
device system has been completely removed.
MR Unsafe-Not for MRI use!
EBI Bone Healing System is indicated for the
®
EBI Bone Healing System on pregnant
®
EBI Bone Healing System has not been tested for
®
7