Medtronic T60050 Instructions for Use

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.

▪ The package label or identifying bar code is illegible or missing.
▪ The expiration date shown on the package label has passed.
▪ If any of the above conditions exist or are suspected, this allograft should not be used.

Note: Once a package seal has been compromised, the tissue should 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.

OPENING INSTRUCTIONS

1. Peel open the outer pouch using proper sterile technique.

2. Pass contents into sterile field.

3. Peel open inner pouch.

An Allograft Tissue Tracing Record is provided. Affix Peel-Off Labels with tissue identification number to patient records and to
the Allograft Tissue Tracing Record. Fill out information and return as directed. Tissue utilization reports are necessary for the
purpose of tracing tissue/recipient information in the unlikely event of suspected or actual transmission of disease and allow for
appropriate actions.

PREPARATION FOR USE

Xpanse™ Bone Insert REQUIRES NO REHYDRATION prior to use. KEEP THE SURGICAL SITE AS DRY AS POSSIBLE.
Fluids such as water, saline or blood may alter the consistency and handling characteristics of Xpanse™ Bone Insert. The
Xpanse™ Bone Insert is designed to expand upon rehydration in vivo. Rehydration prior to implantation will change the physical
dimensions of the graft and may complicate implantation.

When Xpanse™ Bone Insert is used in combination with autologous bone tissues, other forms of allografts or other bone
grafting materials, it is recommended to remove from these graft materials any excess fluids (including rehydration solution)
before the other grafts come into contact with Xpanse™ Bone Insert.

STORAGE

See package label for specific storage conditions. 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.

RETURNS

For any product returned to Medtronic, a Return Authorization Number is required prior to returning this product. Refer to
Medtronic’s Return Policy.

MRI INFORMATION

MR Safe
Xpanse™ Bone Insert is MR Safe.
Xpanse™ Bone Insert 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, the Xpanse™ Bone Insert is not
susceptible to heating due to RF (radio frequency) fields. As such, the Xpanse™ Bone Insert can justifiably be labeled as MR­Safe per ASTM F2503.

If Xpanse™ Bone Insert 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.

REFERENCES

▪ Standards for Tissue Banking (current version), American Association of Tissue Banks, McLean, VA.
▪ Current Policies and Procedures of Medtronic, Eatontown, N.J.
▪ 21 CFR 1271 “Human Cells, Tissues and Cellular and Tissue-Based Products
▪ PHS Guidelines for Preventing Transmission of HIV through Transplantation of Human Tissue and Organs, MMWR

1994:43, 1-17.

▪ 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.

▪ 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.

▪ 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.

©2018 Medtronic Sofamor Danek USA, Inc. All rights reserved.

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

Consult instructions for use

Sterilized using aseptic processing techniques

Do not re-use

Manufacturer

Use-by date

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

Do not use if package is damaged

Batch code

MR Safe

Catalogue number

Date of Manufacture

For US audiences only

Serial Number