The Clinical Perspective

Instructions for Use: Puros Particulate Allografts

• After exposure of the bony defect with mucoperiosteal flap, all granulation tissue must be carefully removed.
• Mix Puros allograft with sterile normal saline solution or patient’s blood.
• Place Puros allograft material in direct contact with well-vascularized and bleeding bone. Cortical bone should be mechanically perforated.
• Place, press-fit and compact firmly the Puros allograft particles into the osseous defect with a sterile instrument. To avoid destroying the trabecular structure of the material, do not use excessive force.
• Avoid overfilling the defect.
• Puros allograft material may be used in conjunction with a resorbable or nonresorbable membrane for guided bone regeneration. Puros allograft provides an effective matrix and guide for development of bone, and its excellent load-bearing capability provides space maintenance and support for the membrane.
• Puros allograft can also be combined with membranes for guided tissue regeneration when grafting periodontal lesions. Mechanical perforation of sclerotic bone at the base of the lesion may enhance osteogenesis.
• If possible, suture mucoperiosteal flaps to achieve primary closure.

A surgical dressing may be placed over the wound for up to two weeks.

Contraindications
Contraindications customary to the use of bone grafts should be observed. In addition, Puros allograft should not be used in patients with:

• Osteomyelitis at the surgical site
• Metabolic diseases (diabetes, hyperparathyroidism, osteomalacia)
• Severe renal dysfunction
• Severe liver disease
• High-dose therapy with corticosteroids
• Vascular impairment at the implant site

Description
The Puros allografts are solvent-dehydrated, limited-dose, gamma-irradiated portions of allogenic human bone. Procurement: All tissue meets stringent donor screening and laboratory testing to reduce the risk of transmitting infectious disease. Processing: The processing of all Puros tissue consists of a strict, quality-controlled procedure that involves thorough cleaning and gentle dehydration of the tissue with solvents. The process leaves no deleterious residue and eliminates antigenic properties. The Puros allografts are used in situations where a human allograft is appropriate, such as dental bone grafting procedures.

Contraindications

• Active or latent infection in or around the surgical implantation site.
• Any disorder which would create an unacceptable risk of postoperative complications.
  

Precautions

• Puros allografts remain sterile and free from endotoxins as long as the package is not opened and/or damaged. The graft must be used before the expiration date.
• Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the graft. Patients should be instructed in the limitations of the graft and should be taught to govern their activities appropriately.
• Appropriate placement and retention are critical factors in the avoidance of potentially adverse effect on graft performance. Ensure that the general principles for working in a sterile environment and using Puros augmentation material are followed.

Utilization/Implantation

• It is recommended that Puros allografts be rehydrated prior to use by soaking in 0.9% saline solution for approximately fifteen (15) minutes using aseptic/sterile technique. Rehydration can also be achieved by mixing the Puros allografts with the patient’s blood.
• As a precaution against incidental contamination after opening, a suitable antibiotic may be added to the soaking solution.

Warnings

• Tutoplast ® processed tissues have been used for over 30 years in more than 1 million surgical transplant cases without a single documented case of disease transmission. As with all biological products, it is not possible to give an absolute guarantee that no infectious disease will be transmitted. However, this risk is greatly reduced by using processing treatments shown to be capable of reducing this risk as well as the use of strict donor screening and laboratory testing.
• The reaction of the body to any allograft is not completely understood.
• Discard grafts when mishandled, or when possible contamination of the graft has occurred.
• Return all packages with flaws in the sterile barrier to the supplier. Do not resterilize.
• Unused bone should be properly discarded.
• Single patient use only.

Adverse Effects

• As with any surgical procedure, the possibility of infection exists.
• Although the Tutoplast process is designed to eliminate antigenic properties of the graft, with no incidence of immunologic rejection after twenty years of use, the possibility of such rejection is present in any allograft procedure.
• Reoperation could be necessary to correct adverse effects.
• Adverse reactions should be immediately reported to Tutogen Medical
  Inc. (U.S.A.) Sterilization. This graft has been sterilized by gamma-irradiation to provide sterility throughout the unit. Storage: this product should be stored in a clean, dry place at a controlled room temperature of 15° to 30° C (59° to 86° F).
  

CAUTION: Federal law (U.S.A.) restricts this material to sale or use by a licensed physician.
Tutogen Medical distributes this tissue without any express or implied warranties. All statements or descriptions are informational only and not made or given as a warranty of the tissues in any way. Tutogen Medical Inc. makes no guarantee whatsoever concerning the biologic or biomechanical properties of the tissue. The user shall be solely responsible for determining the adequacy and appropriateness of the tissue for any uses to which the user shall apply the tissue.

Tutoplast is a registered trademark of Tutogen Medical, Inc.