Product Description
This package contains donated human tissue intended for
transplantation. Puros products are manufactured from human bone that
has been through the BioCleanse® process and terminally
sterilized. This product is restricted to homologous use for the
repair, replacement or reconstruction of musculoskeletal defects by a
qualified healthcare professional (i.e., physician).
Special Instructions and Warnings
- Once opened, the graft must be used for the current procedure
or discarded. Product is a single patient, single use product.
- Do not use damaged, contaminated or expired product.
- This product has been sterilized; do not re-sterilize.
- Manipulation or alterations made to a pre-shaped or assembled
graft can cause graft failure.
- Do not use any tool that
would result in concentrated pressure or force to the cancellous
bone area of the graft, if applicable.
- Tools used for
impaction should distribute pressure evenly across the cortical
area(s).
- Inadequate hydration may result in graft damage upon
impaction.
- Inappropriate placement and/or fixation could lead
to graft migration or could adversely affect performance over
time.
- Prior to performing surgery, the surgeon should be
familiar with surgical techniques or surgical guides for any product
or instruments that will be used.
- Additional products of
varying types and sizes should be accessible in case of an
unexpected need.
- This allograft and all packaging materials
used by RTI are latex free.
- Sterile barrier packaging is
protected by a dust barrier (e.g. box, sealed plastic pouch).
Adverse Reactions
Surgeons should discuss the following potential complications of
tissue transplantation with their patients:
Loss of function and/or integrity of transplanted tissue due to
resorption, fragmentation, and/or disintegration including, but not
limited to, associated loss of continuity, displacement, bending
and/or fracture.
Transmission of known infectious agents including, but not limited
to, HIV, Hepatitis B, Hepatitis C, syphilis and bacteria.
Immune rejection of transplanted grafts or allergic reactions to
residual chemicals. This product may contain trace amounts of the
following processing chemicals: ascorbic acid, detergent, hydrochloric
acid, hydrogen peroxide, isopropyl alcohol, phosphate buffered saline, povidone-iodine.
The same medical/surgical conditions that may complicate any
surgical procedure may occur during or following the transplantation
of an allograft.
