Traditional Allograft Tissue M708348B352E Rev. B
2017-02-10
PACKAGE INSERT AND REHYDRATION INFORMATION
READ BEFORE USE
THIS ALLOGRAFT IS DERIVED FROM HUMAN TISSUE WHICH WAS GENEROUSLY DONATED SO THAT OTHERS MAY
BENEFIT.
THIS ALLOGRAFT IS INTENDED FOR SINGLE PATIENT, SINGLE USE ONLY.
CAUTION: RESTRICTED TO USE BY A PHYSICIAN OR DENTIST.
NO ADDITIONAL STERILIZATION STEP IS TO BE PERFORMED BY THE USER.
DESCRIPTION
This allograft was prepared from tissue recovered from a cadaveric donor using aseptic surgical techniques and
microbiologically tested during recovery. This allograft was further processed and packaged under aseptic conditions. This
allograft was prepared from tissues that may have been cleaned using 70% alcohol, washed with purified water, and sonicated.
This allograft may also have been processed with an additional surfactant. Cleaning, cutting, sizing, shaping, container
sterilization, and filling were performed using aseptic techniques in a controlled environment.
USE
This allograft can be used in a variety of orthopedic and reconstructive applications or dental applications when appropriate. It
can be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or used by itself
as an individual bone allograft.
This package is intended for single patient use only. Do not use the contents of this package for multiple patients.
Preparation of the bone graft bed is important for allograft incorporation and bone formation, as are other factors such as: blood
supply, source of marrow elements, loading, stability, and absence of infection at the graft site.
PACKAGING AND LABELING
This allograft was packaged in single patient use containers and the serial/lot number (including donor ID number), expiration
date, product code, size, and additional information are listed on the package label.
CAUTION
This allograft may contain trace amounts of antibiotics (gentamicin), antiseptic (povidone-iodine), surfactant, and alcohol
solutions. Caution should be exercised if the patient is allergic to these antibiotics or chemicals.
PRECAUTIONS
Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have
been used in the qualification of all tissue donors. Despite the extensive tissue donor selection and qualification processes used
in providing this tissue allograft (see below), transmission of a communicable disease through the use of this tissue allograft is
still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially attributable to this graft must
be reported promptly to Medtronic.
Lyophilized tissue (except for dental applications) must be rehydrated prior to implantation. Failure to rehydrate lyophilized
tissue for the specified amount of time (see General Instructions) may leave the tissue more brittle and susceptible to breakage
during implantation.
CONTRAINDICATIONS
The presence of infection at the transplantation site is a contraindication for the use of this allograft.
DONOR SCREENING AND TESTING
Prior to donation, the donor’s blood, tissues, medical/social history were screened for medical conditions or disease processes
that would contraindicate the donation of tissues in accordance with current FDA policies and standards established by the
American Association of Tissue Banks (AATB). The donor’s medical/social history was screened for HIV, Hepatitis and CJD/
vCJD high risk factors in accordance with current US public health services recommendations and FDA federal regulations and
guidance documents.
Testing of donor blood and tissue samples began at the site of recovery and continued into processing. Donor blood samples
taken at the time of recovery were tested for communicable disease by a laboratory registered with the FDA to perform donor
testing and certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) (42 U.S.C. 263a) and 42 CFR Part 493 using FDA approved, licensed, or cleared tests including, but not limited to:
HBsAg Hepatitis B Surface Antigen
HBc-IgM/IgG Hepatitis B Total Core Antibody
HCV Hepatitis C Antibody
HIV 1/2-Ab Antibody to Human Immunodeficiency Virus Types 1 and 2
RPR/STS or Equivalent Syphilis Detection
HIV 1 NAT Human immunodeficiency virus type 1 nucleic acid amplification testing
HCV NAT Hepatitis C virus nucleic acid amplification testing
The results of all the relevant communicable disease tests referenced above were found to be negative.
In addition to the tests listed above, other tests may have been performed including, but not necessarily limited to, tests for HBV
NAT (Hepatitis B virus nucleic acid amplification testing) and WNV NAT (West Nile Virus nucleic acid amplification testing). If
HBV NAT and WNV NAT tests were performed, the results of these tests were negative or non-reactive, and the results of any
other tests performed were negative or otherwise acceptable for eligibility of donors of musculoskeletal tissues.
The communicable disease test results, together with the informed consent, medical history interview, physical assessment,
available medical records (to include previous medical history, laboratory test results, autopsy and coroner reports, if
performed), and information obtained from any source or records which may pertain to donor eligibility, have been evaluated,
and are sufficient to indicate that donor eligibility criteria, current at the time of recovery, have been met. The donor eligibility
criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Parts 1270 and/or Part 1271,
as applicable.
Donor eligibility was determined by one of the following tissue banks:
American Tissue Services Foundation
Surprise, AZ 85378
Community Tissue Services
Dayton, OH 45402
LifeNet Health
Virginia Beach, VA 23453
RTI Surgical, Inc.
Alachua, FL 32615
The names and addresses of the testing laboratories, the listing and interpretation of all required communicable disease tests, a
listing of the documents reviewed as part of the relevant medical records, and the name of the person or establishment
determining the eligibility of this human tissue are on file at Medtronic and are available upon request.
The final, processed tissue allograft was released by Medtronic based on the initial donor eligibility determination and on a postprocessing review and determination that the allograft met all processing requirements and allograft specifications.
This tissue has been released for transplantation.
STERILITY
Allograft products have been aseptically processed and tested for sterility, as indicated by the package label and as explained
below. Do not subject this allograft to additional disinfection or sterilization procedures.
Tissue labeled as “Aseptically Processed, Passes USP Sterility Tests” or “Sterile” was aseptically processed and then tested for
sterility according to the procedures in the current U.S. Pharmacopeia.
TREATMENT WITH LOW-DOSE GAMMA IRRADIATION
Medtronic may use low dose gamma irradiation as an adjunct to aseptic processing to reduce bioburden as described below.
Labels containing “Treated with Gamma Irradiation”, indicate that low dose (1.0 - 1.8 megarads) gamma irradiation was used as
a means of reducing the tissue bioburden on the donor.
TISSUE TRACKING
Federal (USA) regulations under 21 CFR 1271 establish requirements for tracking of human tissue products. In accordance with
these regulations, the package label of each tissue unit distributed by Medtronic bears a lot or serial number that serves as a
distinct identification code and that is recorded in Medtronic’s distribution records for purposes of tracking the tissue to the
consignee or user/tissue transplant facility. This lot or serial number should be recorded in the user/tissue transplant facility’s
records and in the tissue recipient's medical record, along with the following information:
1. Description of Tissue
2. Lot Number (Donor ID)
3. Product Code
4. Expiration Date
5. Quantity Implanted
If for any reason the graft is opened and not utilized, it should be disposed of properly or returned to Medtronic. Document the
reason for the graft not being utilized.
6. Antibiotics Used
7. Description of Procedure
8. Date and Time of Procedure
9. Surgeon Name
10. Any Other Pertinent Information