DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 6

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Irrita@onal injury of soT @ssues, including impingement syndrome.
Sensi@vity, allergies or other reac@on to the device material. The DynaNail TTC
Fusion System includes nickel and @tanium materials. If sensi@vity to nickel or
@tanium is suspected, appropriate tes@ng should be conducted prior to use.
Tissue reac@ons including macrophage and foreign body reac@ons adjacent to
implants.
Pain, discomfort or abnormal sensa@ons due to presence of the implant.
Hematoma or thrombosis.
Adverse effects may necessitate reopera@on, revision or removal surgery and/or
amputa@on of the limb. Implant removal should be followed by adequate
postopera@ve management to avoid fracture or refracture.
To minimize possible interference risks during medical imaging such as magne@c
resonance imaging (MRI), advise the pa@ent to men@on that he/she was implanted
with a metallic device.
7. PATIENT SELECTION INFORMATION
The surgeon is responsible for paMent selecMon. When evalua@ng pa@ents for
implanta@on using the DynaNail TTC Fusion System, always consider the
pa@ent’s weight, occupa@on, ac@vity level and the presence of any degenera@ve
disease.
The surgeon is responsible for understanding the appropriate indica@ons and
contraindica@ons associated with the device and selec@ng the surgical procedures
and techniques determined to be best for each individual pa@ent. Each surgeon
must evaluate the appropriateness of the device and the procedure used to
implant the device based on his/her own training and experience.
The physician must determine if the device is appropriate for paMents having any
of the following physical or emoMonal condiMons:
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Drug and/or alcohol and/or smoke addic@on and/or abuse.
Infec@ous disease.
Malignancy.
Local bone tumors.
Systemic or metabolic disorders or replacement.
Compromised wound healing.
Obesity.
Demonstrated psychological instability, inappropriate mo@va@on or adtude.
Unwillingness to accept the possibility of mul@ple surgeries for
revision or replacement.
Lacks an understanding that a metallic implant is not as strong as normal
healthy bone and will bend, loosen, or fracture if excessive demand is placed
on it.
Lacks an understanding that their preopera@ve capacity may not be
fully recovered even aTer successful implanta@on.