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
BEFORE USAGE: EXAMINE ALLOGRAFT PACKAGE – DO NOT USE THIS ALLOGRAFT IF:
1. Any of the package or graft elements appear to be missing, tampered with or damaged.
2. The package label or identifying bar code is illegible or missing.
3. The expiration date shown on the package label has passed.
4. Frozen allograft has not been stored according to storage temperature requirements or the allograft has been prematurely
thawed.
If any of the above conditions exist or are suspected, this allograft should not be used.
GENERAL INSTRUCTIONS
1. All lyophilized tissue must be rehydrated for a minimum of 60 minutes except for dental applications. Fluids such as sterile
saline (0.9%), Lactated Ringer’s, or other sterile isotonic solution may be used as rehydration solution.
2. Some freeze-dried bone and soft tissue allografts are packaged with gauze. If gauze is present with the tissue, remove
gauze and discard.
3. Once a package seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded.
Used allograft containers should be disposed of in accordance with recognized procedures for discarding medical waste
material.
Preparation of Lyophilized (Freeze-dried) Allograft in Nested Plastic Trays
Note: this allograft is packaged so that the inner tray and its contents may be passed into the sterile field. Use standard aseptic/
sterile technique to open the package and make ready for use.
Open tissues packaged in nested plastic trays using the following procedure:
1. Peel back lid of outer tray.
Note: once the outer tray is opened, allograft should be used promptly. The inner tray itself is not intended for storage of
allograft.
2. Grasp the pull tab on the lid of the inner tray to remove it from the outer tray and pass it into the sterile field.
3. Peel back lid of inner tray. Transfer ti ssues to a sterile container for rehydration.
4. Completely immerse the tissue in the rehydration solution.
5. Rinse each tissue thoroughly with sterile irrigant prior to transplantation.
Preparation of Lyophilized (Freeze-dried) Allograft in Glass Bottles Not Requiring Rehydration:
(Dental Crushed Cortical Cancellous Product)
1. Remove aluminum cap from container.
2. Remove rubber stopper with the aid of a large sterile clamp in order not to contaminate the opening of the bottle.
Note: the container should be held firmly on a hard surface while removing the stopper to prevent spilling.
3. Deposit the contents of the bottle into a sterile container on the operative field. If desired by the surgeon, this container can
be prefilled with an antibiotic solution.
4. Rinse tissue thoroughly with sterile irrigant prior to transplantation.
Preparation of Lyophilized (Freeze-dried) Allograft in Glass Bottles to be Rehydrated
Open freeze-dried tissues packaged in glass bottles using the following procedure:
1. Remove aluminum cap from container and wipe entire stopper target area with an iodophor solution, such as betadine, or
70% alcohol.
2. Using aseptic technique, deliver the rehydration solution into the container by puncturing the stopper with a needle attached
to a syringe, I.V. administration set, or other appropriate delivery system. All components used for the delivery of the
rehydration solution must be sterile. Completely immerse the tissue with the rehydration solution. The solution should be
drawn into the vial by the vacuum inside the container (this assures that a vacuum is present). If the solution is not drawn
into the vial, repeat the process with a different needle to assure that coring of the stopper did not block the needle opening.
Do not use tissue if vacuum does not appear to be present.
3. Remove rubber stopper with the aid of a large sterile clamp in order not to contaminate the opening of the bottle.
Note: the container should be held firmly on a hard surface while removing the stopper to prevent spilling.
4. Deposit the contents of the bottle into a sterile container on the operative field. If desired by the surgeon, this container can
be prefilled with an antibiotic solution.
5. Completely immerse the tissue with the rehydration solution.
6. Rinse each tissue thoroughly with sterile irrigant prior to transplantation stopper to prevent spilling.
Preparation of Frozen Allograft
Before use, the allograft must be thawed using aseptic technique. The allograft must not be refrozen after thawing.
1. Thaw tissue using one of the following methods:
a. Slow Thaw Method: Approximately 24 hours prior to surgery, move the packaged allograft from freezer to refrigerator
(2°C to 8°C). Do not open the package until immediately before use. When needed for surgery, follow the unwrapping
procedure and proceed as described below.
b. Ouick Thaw Method: Follow the instruction for removing allograft from packaging. Immerse the allograft in sterile saline
(0.9%), Lactated Ringer's, or other sterile isotonic solution for 30 to 60 minutes. The solution used for thawing may be
warmed to a maximum of 40°C for rapid thawing. DO NOT MICROWAVE THE ALLOGRAFT.
2. Remove allograft from its packaging:
Handling instructions for Allograft Tissue Delivery System:
Cut open outer bag with non-sterile scissors and remove peel pouch.Using proper aseptic technique, open the peel pouch to
expose the vacuum-sealed bag.Hand off the vacuum-sealed bag onto sterile field.
3. Cut open vacuum-sealed bag with sterile scissors and remove allograft.
4. Place the allograft in a sterile basin containing sterile isotonic solution and cover the basin with a sterile towel until use.
Allografts must be used promptly after thawing and must not be refrozen. Allografts must be used within six hours after
thawing if the allograft is stored at room temperature. If refrigerated between 2°C and 8°C within six hours after thawing, the
allograft may be used within 24 hours (including thaw time) if stored with proper precautions to prevent contamination.
See package label for specific storage temperature requirements. It is the responsibility of the transplant facility or clinician to
maintain the tissue intended for transplantation in the appropriate recommended storage conditions prior to transplant.
Note: for frozen allograft, if the allograft is to be stored at a temperature between -20ºC and -40ºC, store only for a period not to
exceed six months.
RETURNS
For any returns deemed necessary as a result of an error by Medtronic or a product complaint, a Return Authorization Number
is required from Medtronic prior to shipping. Full credit will be issued. For returns other than an error by Medtronic or a product
complaint, refer to Medtronic’s Return Policy.
MRI INFORMATION
MR Safe
Traditional Tissue is MR Safe.
Traditional Tissue is a nonconducting or a nonmagnetic item which poses no known hazards in all MR environments for
magnetically induced displacement force and magnetically induced torque. In addition, Traditional Tissue are not susceptible to
heating due to RF (radio frequency) fields. As such, Traditional Tissue can justifiably be labeled as MR-Safe per ASTM F2503.
REFERENCES
1. Standards for Tissue Banking (current version), American Association of Tissue Banks, McLean, VA.
2. Current Policies and Procedures of Medtronic.
3. FDA Final Rule for “Current Good Tissue Practice for Donors of Human Cell, Tissue and Cellular and Tissue-Based
Products”, 21 CFR Parts 16, 1270 and 1271, Federal Register, November 24, 2004 (Volume 69, Number 226) pg
68611-68688.
4. PHS Guidelines for Preventing Transmission of HIV through Transplantation of Human Tissue and Organs, MMWR
1994:43, 1-17.
5. PHS Guideline for Screening Donors of Blood, Plasma, Organs, Tissue and Semen for Evidence of Hepatitis B and
Hepatitis C, MMWR 1991:40, 1-17.
6. FDA Recommendations to Blood Establishments for “Deferral of Current and Recent Inmates of Correctional Institutions as
Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma,” 6/8/95.
7. FDA Recommendations to Blood Establishments for “Precautionary Measures to Further Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease By Blood and Blood products,” 8/8/95.
8. FDA Final Rule for “Eligibility Determination of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products”,
21 CFR Parts 210, 211, 820 and 1271, May 24, 2004, Federal Register, Vol. 69, No.101, pg. 29785-29834. CTO
Registration # 100138 (Canada).
If Traditional Allograft Tissue is used in connection with any device which is not MR Conditional, please be advised that this
combination has not been tested in the MR environment and, therefore, higher heating and possible injury to the patient may
occur.
Allogard
©2017 Medtronic Sofamor Danek USA, Inc. All rights reserved.
®
, OsteoActive®, Advancing OsteoBiologic Sciences®, and Osteotech® are registered trademarks of Osteotech.
DISTRIBUTED BY:
SpinalGraft™ Technologies LLC
4340 Swinnea Road, Suite 39
Memphis, TN 38118
DESCRIPTION OF DEVICE MARKINGS
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
30 °C
15 °C
Temperature limit
Manufacturer
Date of Manufacture
For US audiences only
Catalogue number
Sterilized using aseptic processing techniques
Do Not Re-use
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
Use-by date
Consult instructions for use
Do not use if package is damaged
MR Safe
Serial Number
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