SYNTHETIC BONE GRAFT BONE GRAFTING (Spine and Orthopaedic)

WHAT IS SYNTHETIC BONE GRAFT? 

Synthetic bone graft, which is artificially produced, bulks up or extends the supply of available autograft bone (bone harvested from your own body). There are many extender biomaterials and tissues available, and their properties depend heavily on their origin and how they are processed.


HOW DOES SYNTHETIC BONE GRAFT WORK?

Synthetics work through a process called osteoconduction. Imagine a vine growing through and around a trellis. Synthetic bone graft works in a similar fashion. It is like a scaffold (trellis) that supports the bone-forming cells (the vine) as they grow new bone over time. 


SYNTHETIC BONE GRAFTING OPTIONS FROM MEDTRONIC

Mastergraft™ products are composed of bovine (cow) collagen and/or a synthetic calcium phosphate material that is similar to the mineral component of natural bone. They come in various shapes and sizes, and they serve as passive scaffolds to which your body’s own bone-forming cells attach for the formation of new bone. These products are intended to be used in combination with your own bone (autograft) in the surgical site, to reduce or eliminate the need to take additional autograft from your hip.


CONTRAINDICATIONS: MASTERGRAFT

This product is not intended to provide structural support during the healing process; therefore, Mastergraft 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 EXT, and 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 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 Important Safety Information.