Healthcare Professionals

Mastergraft Family of Products

Bone Grafting (Oral-Maxillofacial and Dental)

OVERVIEW

Mastergraft™ bone graft products are osteoconductive, resorbable scaffolds that extend autograft and facilitate the delivery — and maintain the viability — of the patient’s own cells.1 These synthetic bone grafts have a proprietary biphasic composition (85% beta-Tricalcium phosphate (B-TCP) and 15% hydroxyapatite (HA)) that supports new bone formation while remodeling into the patient’s own bone. Mastergraft is provided as standalone granules or combined with collagen to create a putty form that provides cohesiveness and moldable characteristics.

We offer three forms of Mastergraft for dental applications: Mastergraft Granules, Mastergraft Mini Granules, and Mastergraft Putty.


INDICATIONS

Mastergraft products may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. Mastergraft products are packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Procedures specific to Mastergraft Granules include:

  • Filling of dental extraction sockets
  • Filling of cystic defects
  • Oral/maxillofacial augmentation or reconstruction

Procedures specific to Mastergraft Mini Granules and Mastergraft Putty include:

  • Filling of periodontal defects
  • Sinus lifts
  • Alveolar ridge augmentation
  • Filling of dental extraction sockets
  • Filling of cystic defects
  • Oral/maxillofacial augmentation or reconstruction

Mastergraft products may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.


SUPPORTIVE DATA

  • Mastergraft synthetic bone graft can be hydrated with cell-rich bone marrow aspirate (BMA).
  • It can act as a carrier and deliver mesenchymal stem cells (MSCs) to the site.1
  • Histological evidence shows new bone formation came from transplanted cells vs. host cells.1*

PRODUCT FEATURES: MASTERGRAFT GRANULES AND MINI GRANULES

Mastergraft granules are medical grade macro and microporous, resorbable ceramic granules.
  • Medical grade macro and microporous, resorbable ceramic granules
  • Each granule is composed of:
    • 15% hydroxyapatite (HA) , slow resorbing2
    • 85% beta-tricalcium phosphate (β-TCP)
      • Fast resorbing2
      • 80% interconnected porosity2
    • 500 µm average pore diameter2
    • 125 µm average interconnected diameter2
  • 85:15 ratio chosen due to:
    • Long-term stability2
    • Resorption rate2

PRODUCT FEATURES: MASTERGRAFT PUTTY

Mastergraft granules are medical grade macro and microporous, resorbable ceramic granules.
  • Resorbable osteoconductive cohesive scaffold
  • Composed of collagen mixed with Mastergraft Mini Granules
    • 70% insoluble
    • 30% soluble Mastergraft Mini Granules
  • 80% ceramic and 20% bovine type collagen
  • Malleable and formable

MANUALS AND TECHNICAL GUIDES

Find technical manuals in the product labeling supplied with product or call Medtronic at 800-961-9055.


CONTRAINDICATIONS

This product is not intended to provide structural support during the healing process, therefore, Mastergraft products are 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
  • 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 Putty should not be used in patients with a known history of hypersensitivity to bovine derived materials.


POTENTIAL ADVERSE EVENTS

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

  • Deformity of the bone at the surgical site
  • Fracture or extrusion of the Mastergraft Granules, 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 information, see Indications, Safety, and Warnings.


*

Animal testing is not necessarily indicative of human clinical outcomes.


1

Kim Hyung-Jun. 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).

2

Data on file.