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MASTERGRAFT® Granules 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® Granules is 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:
Procedures specific to MASTERGRAFT® Mini Granules include:
MASTERGRAFT® Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
This product is not intended to provide structural support during the healing process, therefore, MASTERGRAFT® Granules is contraindicated where the device is intended as structural support in the skeletal system.
Conditions representing relative contraindications include:
A listing of potential adverse events includes, but is not limited to:
A 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, or immunosuppressive therapy, or high dosage radiation therapy.
MASTERGRAFT® Granules 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.
WARNING: NEVER USE THIS DEVICE IF THE VIAL IS CRACKED OR BROKEN.
PHYSICIAN and DENTIST NOTE: Although the physician or dentist is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.
MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is 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 include:
MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
This product is not intended to provide structural support during the healing process; therefore, MASTERGRAFT® Putty is contraindicated where the device is intended as structural support in the skeletal system. Conditions representing relative contraindications include:
MASTERGRAFT® Putty should not be used in patients with a known history of hypersensitivity to bovine derived materials.
A listing of potential adverse events includes, but is not limited to:
A successful result is not always achieved in every surgical case.
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, or immunosuppressive therapy, or high dosage radiation therapy.
MASTERGRAFT® Putty 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 or dentist 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 US AUDIENCES ONLY
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.