The OSSURE implant material can be seen under certain types of radiographic
imaging like CT scans or X-rays. It is safe to have an MRI if you have the OSSURE implant. The OSSURE
implant material is non-metallic. The OSSURE implant material is not expected to cause problems during
regular medical examinations. Weather and the outdoors are not expected to affect the OSSURE implant.
OSSURE Implant Material: Each OSSURE LOEP Kit contains the powder
and liquid components needed to produce up to 25cc of OSSURE Implant Material. The powder components
consist of calcium salts that are packaged in a sealed, polycarbonate dual powder container. The
neutralized glycolic acid liquid component is packaged in a capped glass vial. The components are as
follows:
Once the powder and liquid components are mixed, the calcium sulfate salts hydrate with water to form
calcium sulfate dihydrate. At the same time, the MCPM and β-TCP dissolve in the liquid and react to form
brushite. During these reactions, a small amount of phosphoric acid is produced, which is quickly
consumed. Any remaining water and glycolic acid are incorporated into the crystal structure of the set
implant material. After mixing and setting, the OSSURE Implant Material is a tri-phasic calcium-based
cement consisting of 75% calcium sulfate (52g), 9% beta tricalcium phosphate ( β-TCP) (6g) granules, and
16% brushite (11g). Upon implantation, the material sets in approximately 20 minutes and reaches more
than 85% of its ultimate strength within 1 hour. Your body will resorb the OSSURE implant material.
Then, the implant material will be replaced with bone 6 to 24 months after it is put in your body.
Stainless steel Surgical Instruments
The surgical instruments provided in the
OSSURE LOEP kit (i.e. the Suction Irrigator, Injection Cannula and Serrated Tissue Protector) are
manufactured from 304 stainless steel and contain trace amounts [>0.1% (wt)] of nickel and cobalt as
alloying elements.
The risks of using the OSSURE LOEP Kit are like the risks of using similar
products. These include: pain, swelling, bruising, infection, dizziness, tissue irritation, blood
blisters and fluid drainage at the injection site and reopening of the incision wound.
Other
possible side effects include A temporary increase in blood calcium levels, poor, incomplete or no bone
formation, weakened bone or bone fracture. The implant material can leak into nearby skin, soft tissue,
or joints. Fat, blood clots, or the implant material may pass into the bloodstream. If these pass into
the bloodstream, they may block arteries in the lungs, cause a heart attack or cause other heart
problems. The passage of materials into the bloodstream can also cause a stroke. A stroke is when the
blood supply to part of the brain is interrupted or reduced. A stroke may cause brain
damage.
Talk to your doctor right away if you have sudden pain, redness, swelling,
inflammation or drainage. Your doctor will give you directions on moving and walking after the
surgery.