Synthetics

Mastergraft™ bone graft

<p>Mastergraft™ bone graft is a synthetic scaffold that comes in versatile formats to support bone healing and remodeling in spinal and orthopedic procedures.</p>

Contact a representative

Indications, Safety, and WarningsIndicationsMASTERGRAFT™ Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender.The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.ContraindicationsThis product is not intended to provide structural support during the healing process. Therefore, MASTERGRAFT™ Matrix EXT 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.

Should not be used in patients with a known history of hypersensitivity to bovine derived materials.

Potential adverse eventsA listing of potential adverse events includes, but is not limited to:
Deformity of the bone at the surgical site.
Fracture or extrusion of MASTERGRAFT™ Matrix EXT 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 in-growth into bone void, as possible with any bone filler.Warnings and precautionsA successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. As with any surgical procedure, care should be demonstrated in treating patients with preexisting conditions that may impact the success of the surgical procedure. This includes patients with bleeding disorders of any etiology, long-term steroidal therapy, immunosuppressive therapy, or high dosage radiation therapy.MASTERGRAFT™ Matrix EXT does not possess sufficient mechanical strength to support reduction of a defect site prior to soft and hard tissue ingrowth. Rigid fixation methods are recommended as needed to ensure stabilization of the defect. Complete postoperative wound closure is essential.Use this device as supplied and in accordance with the handling and use information provided.This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.Warning: Never use this device if the packaging is compromised.Physician note: Although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.For U.S. Audiences onlyCAUTION: Federal law (United States) restricts these devices to sale by or on the order of a physician.

Features

Available in granules, putty, strip, and matrix EXT formats, Mastergraft™ is indicated for bony voids or gaps not intrinsic to structural stability and can be used as a bone graft extender in spine, pelvis, ilium, and extremity procedures.

The Mastergraft™ family facilitates the delivery — and maintains the viability — of the patient’s own cells.² The interconnected porosity allows for cell infiltration, vascularization, and space for new bone formation.^†,2,3,6,7

91% radiographic fusion rate

in a rabbit study using 50/50 allograft/autograft^†,4

Mastergraft™ matrix EXT

This compression-resistant matrix combines Mastergraft™ granules with collagen and is designed for use with bone marrow aspirate.

Mastergraft™ putty

Mastergraft™ putty is a moldable and formable, composed of 80% ceramic and 20% bovine type I collagen.

Mastergraft™ granules

Medical-grade macro and microporous ceramic granules and mini-granules offer 80% interconnected porosity.^†,3,5 

Mastergraft™ strip

Mastergraft™ strip has a flexible scaffold designed for packing into irregular defects.

Biologic compatibility

Acts as a cell carrier for mesenchymal stem cells (MSCs), facilitating colonization and bone formation.^‡,3
Compatible with SmartStorage™, an RFID-based tissue tracking system for inventory and compliance.

Engineered chemistry

Biphasic composition (85% β-TCP, 15% HA) balances fast and slow resorption.¹
Average pore diameter: 500 µm; interconnected diameter: 125 µm.

† Data on file. Animal studies are not necessarily indicative of human clinical outcomes.

‡ Data on file. In Vitro testing not indicative of human clinical outcomes.

Wakimoto M, Ueno T, Hirata A, Iida S, Aghaloo T, et. al. Histologic evaluation of human alveolar sockets treated with an artificial bone substitute material. J Craniofac Surg. 2011 Mar;22(2):490–3. doi: 10.1097/SCS.0b013e318208bacf. PMID: 21415629; PMCID: PMC4045110.

Zannettino AC, Paton S, Itescu S, Gronthos S. Comparative assessment of the osteoconductive properties of different biomaterials in vivo seeded with human or ovine mesenchymal stem/stromal cells. Tissue Eng Part A. 2010 Dec;16(12):3579-87. doi: 10.1089/ten.TEA.2010.0153. Epub 2010 Aug 30. PMID: 20666614.
Data on file at Medtronic.
Smucker, J. D., E. B. Petersen, J. V. Nepola, and D. C. Fredericks. “Assessment of Mastergraft Putty as a Graft Extender in a Rabbit Posterolateral Fusion Model.” Spine 37, no. 12 (2012): 1017–21. Reports 91% radiographic fusion and 73% manual palpation fusion for 50% putty composite, outperforming autograft alone.
Zou C, Zhang E, Li M, Zeng S. Preparation, microstructure and mechanical properties of porous titanium sintered by Ti fibres. J Mater Sci Mater Med. 2008 Jan;19(1):401-5. doi: 10.1007/s10856-006-0103-0. Epub 2007 Jul 3. PMID: 17607525.
Kim HJ, Park JB, Lee JK, Park EY, Park EA, Riew KD, Rhee SK. 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 Nov;17(11):1515- 21. doi: 10.1007/s00586-008-0784-9. Epub 2008 Sep 25. PMID: 18815818; PMCID: PMC2583184.
Dunkley IR, Vickers SM, Badura J, Toth J. A Histological Assessment of the Mechanism of Early-Stage Healing of a Biphasic Calcium Phosphate in an In Vivo Rabbit Model. KEM 2018;782:275–82