Bone Grafting (Spine and Orthopaedic) HEALTHCARE PROFESSIONALS

GRAFTON™ DBM

The most used and scientifically studied DBM brand

Grafton™ demineralized bone matrix (DBM) is the most used and scientifically studied DBM brand.1 Our aseptic processing technology preserves the function of naturally occurring growth factors — yielding Grafton DBM’s osteoinductivity scores. Proprietary fiber technology offers enhanced osteoconductive scaffold.2

Indications, Safety, and Warnings

Product Details

MASTERGRAFT™ FAMILY

Synthetic, osteoconductive, resorbable scaffolds support new bone formation while remodeling

The Mastergraft™ family of products are osteoconductive, resorbable scaffolds that may be used as bone graft substitutes and to extend autograft. Mastergraft™ products facilitate the delivery and maintain the viability of the patient's own cells.3 The product portfolio provides the Mastergraft™ technology as standalone granules, as a moldable/packable putty, and as a compression resistant and flexible strip. These synthetic bone grafts deliver a proprietary biphasic calcium phosphate (85% beta-tricalcium phosphate (B-TCP) and 15% hydroxyapatite (HA) in porous granules alone or in combination with bovine type I collagen. The biphasic chemistry and macro- and microporous structure is specifically engineered to balance new bone formation while remodeling into the patient's own bone.

Indications, Safety, and Warnings

Product Details

MedishieldTM

medishield product image

MediShieldTM creates a barrier to separate tissues during the initial stages of the healing process.

Indications, Safety and Warnings

Product Details

NanostimTM

nanostim product image

NANOSTIM™ Synthetic Bone Paste is a water-based bone grafting paste that uses nanotechnology to facilitate new bone formation and bone healing.

Indications, Safety and Warnings

Product Details

SPINAL INDICATIONS

GRAFTON™ DBM: CONTRAINDICATIONS

The following are contraindications for the use of Grafton™ DBM and Grafton Plus™ DBM:

  • The presence of infection at the transplantation site
  • Treatment of spinal insufficiency fractures

GRAFTON™ DBM: CAUTION

This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Caution should be exercised if the patient is allergic to these antibiotics or chemicals. Grafton Plus™ DBM paste contains starch. Therefore, caution should be exercised in using Grafton Plus™ DBM paste in a patient with a starch allergy and/or amylase deficiency.

For more details see Indications, Safety, and Warnings.

GRAFTON™ DBF FAMILY: CAUTION

This allograft may contain trace amounts of antibiotics (gentamicin) and processing solutions. Caution should be exercised if the patient is allergic to these antibiotics or processing solutions.

GRAFTON™ DBF FAMILY: CONTRAINDICATIONS

The presence of infection at the transplantation site is a contraindication for the use of this allograft.

For more details, see Indications, Safety, and Warnings.

MASTERGRAFT™: CONTRAINDICATIONS

This product is not intended to provide structural support during the healing process; therefore, Mastergraft™ family is contraindicated where the device is intended as structural support in the skeletal system. Conditions representing relative contraindications include:

  • Severe neurological or vascular disease
  • Uncontrolled diabetes
  • Hypercalcemia
  • Pregnancy
  • Where stabilization of fracture is not possible
  • Segmental defects without supplemental fixation
  • Where there is significant vascular impairment proximal to the graft site
  • When there are systemic and/or metabolic disorders that affect the bone or wound healing
  • Any patient unwilling to follow postoperative instructions
  • Any case not described in the indications

Mastergraft™ strip, Mastergraft™ matrix, and Mastergraft™ putty should not be used in patients with a known history of hypersensitivity to bovine derived materials.

MASTERGRAFT™: POTENTIAL ADVERSE EVENTS

A list of potential adverse events includes, but is not limited to:

  • Deformity of the bone at the surgical site
  • Fracture or extrusion of Mastergraft™ with or without generation of particulate debris
  • Wound complications including hematoma, site damage, infection, bone fracture, and other complications common to any surgical procedure
  • Incomplete, or lack of, osseous ingrowth into bone void, as possible with any bone filler

For more details see Indications, Safety, and Warnings.

1

Based on Pub-Med search on 8/26/14 with key words Grafton™ DBM, DBX™*, and Osteosponge™*

2

Martin GJ, Boden SD, Titus L, Scarborough NL New Formulations of Demineralized Bone Matrix as a More Effective Graft Alternative in Experimental Posterolateral Lumbar Spine Arthrodesis. Spine. 1999;24(7):637-645.

3

Kim et al, Transplanted xenogenic bone marrow stem cells survive and generate new bone formation in the posterolateral lumbar spine of non-immunosuppressed rabbits, Eur Spine J 2008, 17:1515–1521.

*

Approved for use in certain spinal, dental, and trauma indications.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu