Puros^®-A and -P Allograft Systems

• Consistent shape and size
  Puros-A and Puros-P implants are available in a wide range of precisely machined sizes, heights and lordotic angles to help you fit varying patient anatomies accurately.
• Designed for stability
  Puros-A and Puros-P implants are created from femoral bone to reduce the likelihood of breakage and provide stability to create an osteoconductive scaffold to facilitate spinal fusion.
  
• Validated tissue sterilization process
  Puros-A and Puros-P Allografts are cleaned and sterilized using RTI’s Tutoplast* process. During the Tutoplast process, osmotic, oxidative and alkaline (membrane tissue only) treatments break down cell walls and inactivate pathogens and remove bacteria. Solvent dehydration results in room temperature storage of tissue without damaging the collagen structure. Low-dose gamma irradiation ensures sterility of final packaged product.

Indications

The Tutoplast^® allografts may be used in situations where an autograft is appropriate, such as spinal fusion procedures.  As with any tissue grafting procedure, the success of treatment with Tutoplast^® allograft is dependent upon the patient’s host tissue response.  Resorption of the allograft tissue with commensurate substitution of functional host tissue is required to restore function to the graft treated site.  Excessive levels of patient activity during graft incorporation, high patient body weight, (in the case of grafted weight bearing sites), poor initial graft fixation, smoking, and other risk factors to tissue healing may be associated with failure of allograft surgery.  Patients should be advised as to the general and specific limitations of allograft surgery and to necessary limitations of functional activity after treatment with allograft tissue as outlined in this document as well as the written and verbal advice of the attending physician.

Contraindications

• Active or latent infection in or around the surgical implantation site.
• Any medical condition or physical condition that would create an unacceptable risk or postoperative complications.
• Any medical condition or physical condition that would preclude the potential benefit of the surgery.
• Diabetes
• Smoking
• Sensitivity/Allergies to the implant material, especially to human collagen.
• Patients who are unwilling or unable to follow postoperative instructions.
• Any medical or mental condition that would exclude the patient or put the patient at high risk for surgery.
• Obesity
• Pregnancy
• Mental Illness
• Severe osteoporosis or osteopenia
• Alcohol or drug abuse

Warnings

As with all biological products, it is not possible to give an absolute guarantee that no infectious disease, such as hepatitis or CJD, 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.
• Allograft bone is incorporated more slowly and more superficially than autografts.
• Due to the risk of fracturing, the allograft must not be tapped or tamped into place.
• Allograft bone is more prone to subsequent fracture and resorption than autograft bone.
• Discard grafts when damaged or mishandled, or when possible contamination of the graft has occurred.
• Return all packages with flaws to the supplier.  Do not resterilize.
• Unused bone must be properly discarded.
• Single patient use, singe use only.
• Allergic reactions to collagen must be ruled out in the history.

Precautions

• Tutoplast^® allografts remain sterile 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 Tutoplast® should be informed about the limitations of the graft and should be instructed to govern their activities appropriately.
• Appropriate placement and fixation are a requirement in order to avoid potentially adverse effects on graft service life.
• To assure postoperative healing without complications, excessive activities during the healing phase have to be avoided.  e.g. sporting activities.

Complications and Possible Adverse Side 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 thirty 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 immediately be reported to Tutogen Medical, Inc.
• Nerve damage, including loss of neurologic function, dural tears, paralysis, paresthesia, and cerebral spinal leakage.
• Bone graft donor site pain, fracture, and/or delayed wound healing.
• Restriction of activities
• Death