This allograft spacer was processed from donated human tissue,
resulting from the generous gift of an individual or his/her family.
The spacer was cleaned and disinfected through a proprietary process
and terminally sterilized via gamma irradiation. There are two
preservation methods included in these instructions: Freeze-Dried, and
packaged with Preservon®. Please refer to the label to
identify which preservation method was utilized for this spacer.
This allograft spacer is intended for implantation.
The contraindications include, but are not limited to: Use in any
patient who has a known or suspected allergy to any of the antibiotics
and/or processing reagents listed in this package insert.
Warnings and Precautions
The same medical/surgical conditions or complications that apply to
any surgical procedure may occur during or following implantation. The
surgeon is responsible for informing the patient of the risks
associated with their treatment and the possibility of complications
or adverse reactions. As with any allograft spacer, the transmission
of infectious agents exists. This spacer may contain residuals of
antibiotics (Bacitracin, Gentamicin, and/or Polymyxin B Sulfate),
alcohol, surfactants, and/or glycerol. Caution should be exercised if
the patient has a known sensitivity to any of these antibiotics and/or reagents.
Potential adverse events or outcomes include, but are not limited
to, disease transmission, infection, allograft tissue rejection,
allergic reaction to residual processing reagents, reoperation and/or
death. Promptly report any adverse event(s) or outcome(s) potentially
attributable to the allograft spacer (See COMPLAINTS AND RETURNS section).