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INSTRUCTIONS

RICH Bone Substitute sintered by calcium phosphate with an interconnective pore system is intended for use to be filled into bone defect. It can be replaced with natural bone gradually during the healing process.

INDICATIONS

Control active bleeding at the implant site.

RICH Bone Substitute can be filled directly into the site of bone defect.

COMPONENTS

Beta-tricalcium phosphate (β-TCP)

ADVERSE EFFECTS AND COMPLICATIONS

Successful results may not be achieved in every surgical case. If any complication occurs, additional surgery to remove or replace the implant may be required. Complications include but are not limited to:

◆Implant fraction, migration

◆  Loss of contour

◆Tissue thinning over implant site

◆Edema, redness or infection

WARRANTY AND PRECAUTIONS

◆RICH Bone Substitute is for single use. Resterilize or use it if the package is opened or damaged will cause cross inflection.

◆When severe bleeding occurs, stop bleeding before applying. Excess may affect the curative effect.

◆RICH Bone Substitute is used for bone repair only, and every step of treatment will followed on aseptic handling technique.

◆Store at cool dry place for extending expiration date.

◆The product is restricted to be used by a physician.

CONTRAINDICATIONS

Each surgeon must evaluate prudently before operation, if there is any contraindication. Contraindication may include but are not limited to:

◆Use for stress bearing applications

◆Use in a currently infected field or surgical site near an infection

◆Use in the implant site that can’t provide structural support to bone

◆Use in patients who have not reached an age at which bones and skeleton growth is essentially complete

◆Use in patients with any metabolic bone disease

◆Pregnancy and breastfeeding feminine

◆Defects due to disease or congenital malformation

◆Use in patients with immunologic abnormalities and systemic disorders which result in poor wound healing or will result in tissue deterioration over the implant site

◆  Granule type

Specification	Particle Size / Reference
	0.2~0.5mm	0.5~1mm	1~2mm	3mm
0.5c.c×2	TP02051-2	TP05101-2	—	—
1 c.c.	TP02051	TP05101	TP10201	TP30001
2 c.c.	TP02052	TP05102	TP10202	TP30002
5 c.c.	—	—	TP10205	TP30005
10 c.c.	—	—	TP102010	TP300010
20 c.c.	—	—	TP102020	TP300020