Xpanse™ Bone Insert M708348B353E Rev. D
2018-07-02
IMPORTANT INFORMATION ON THE XPANSE™ BONE INSERT
READ BEFORE USE
THIS GRAFT IS DERIVED FROM HUMAN TISSUE WHICH WAS GENEROUSLY DONATED SO THAT OTHERS MAY
BENEFIT.
EACH UNIT IS INTENDED FOR SINGLE PATIENT, SINGLE PROCEDURE ONLY.
CAUTION: RESTRICTED TO USE BY A PHYSICIAN, PODIATRIST OR DENTIST.
NO ADDITIONAL STERILIZATION STEP IS TO BE PERFORMED BY THE USER.
DESCRIPTION
Xpanse™ Bone Inserts are comprised of banked human bone tissue that has been demineralized. This allograft was prepared
from tissue recovered from a cadaveric donor using aseptic surgical techniques. This allograft was further processed and
packaged under aseptic conditions. This allograft was prepared from tissues that were treated with antibiotics (gentamicin),
cleaned using 70% alcohol, washed with purified water, and sonicated. This allograft may also have been processed with an
additional surfactant. These tissues were demineralized so that the resulting bone matrix has a calcium phosphate content level
that meets current American Association of Tissue Banks (AATB) standards. Demineralized bone fibers were combined with
demineralized cancellous chips, to form the final allograft product.
Xpanse™ Bone Inserts include demineralized bone allograft fibers that are osteoconductive as well as osteoinductive in an
athymic rat assay.
Xpanse™ Bone Insert is prepared via a proprietary processing service of Medtronic.
USE
Caution: Xpanse™ Bone Insert is restricted to use by a physician, podiatrist or dentist.
Xpanse™ Bone Insert can be used in orthopedic or reconstructive bone grafting procedures. The product can also be used in
bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft.
The contents of an individual Xpanse™ Bone Insert container are intended for single patient, single use only. Do not use the
contents of any container for multiple patients. Empty or partially used containers should be disposed of in accordance with
recognized procedures for discarding medical waste materials.
Preparation of the bone graft bed is important for graft 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. The volume of graft material used
in each procedure is determined by the judgement of the clinician.
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 viral inactivation and extensive tissue donor selection and
qualification processes used in providing this tissue graft (see below), transmission of a communicable disease through the use
of this tissue graft is still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially
attributable to Xpanse™ Bone Insert must be reported promptly to Medtronic.
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, and medical/social history were screened for medical conditions or disease
processes that would contraindicate the donation of tissues in accordance with current FDA regulations and standards
established by the American Association of Tissue Banks (AATB). The donor’s medical/social history was also screened for
HIV, Hepatitis and CJD/vCJD high risk factors in accordance with current US Public Health Services recommendations and FDA
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:
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 or non-reactive.
In addition to the tests listed above, other tests may have been performed including, 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 and social 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.
Based on this evaluation, the donor was determined to meet donor eligibility criteria current at the time of recovery. The donor
eligibility criteria used to screen this donor are in compliance with FDA regulations published in 21 CFR Part 1271, “Human
Cells, Tissues, and Cellular and Tissue Based Products”, 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, Eatontown, NJ 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
Xpanse™ Bone Inserts 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 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 “Pretreated with Gamma Irradiation” indicate that the 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:
▪ Any of the package materials or contents appear to be missing, tampered with, or damaged.
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