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.
- Active or latent infection in or around the surgical
- Any medical condition or physical
condition that would create an unacceptable risk or postoperative
- Any medical condition or physical condition
that would preclude the potential benefit of the surgery.
- Sensitivity/Allergies to the
implant material, especially to human collagen.
who are unwilling or unable to follow postoperative
- Any medical or mental condition that would
exclude the patient or put the patient at high risk for
- Severe osteoporosis or osteopenia
- Alcohol or
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
- 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
- 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
- Return all packages with flaws to the
supplier. Do not resterilize.
- Unused bone must be properly
Single patient use, singe use only.
reactions to collagen must be ruled out in the history.
- 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.
placement and fixation are a requirement in order to avoid
potentially adverse effects on graft service life.
assure postoperative healing without complications, excessive
activities during the healing phase have to be avoided. e.g.
Complications and Possible Adverse Side Effects
- As with any surgical procedure the possibility of infection
- 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
- Nerve damage, including loss of neurologic
function, dural tears, paralysis, paresthesia, and cerebral spinal
- Bone graft donor site pain, fracture, and/or delayed
- Restriction of activities