商品介紹

Bone Substitute (Granule)

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

Bone Substitute (Block)

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

Block type

Specification

Reference

1 c.c.

TPB10

2.5 c.c.

TPB25

5 c.c.

TPB50

10 c.c.

TPB100

20 c.c.

TPB200

30 c.c.

TPB300