INDICATIONS, SAFETY, AND WARNINGS MASTERGRAFT FAMILY OF PRODUCTS

INDICATIONS, SAFETY, AND WARNINGS BY PRODUCT TYPE


IMPORTANT INFORMATION ON MASTERGRAFT GRANULES AND MINI GRANULES

INDICATIONS

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:

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

Procedures specific to MASTERGRAFT® Mini Granules 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® Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

CONTRAINDICATIONS

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:

  • 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

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.

WARNINGS AND PRECAUTIONS

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.

IMPORANT INFORMATION ON MASTERGRAFT PUTTY

INDICATIONS

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:

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

MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

CONTRAINDICATIONS

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:

  • Severe neurological or vascular disease.
  • Uncontrolled diabetes.
  • Hypercalcemia.
  • Pregnancy.
  • Where stabilization of fracture is not possible.
  • 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 MASTERGRAFT® Putty, 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.

WARNINGS AND PRECAUTIONS

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.