Medtronic T00962INT Instructions for Use

MinerOss™ Cortical & Cancellous

M708348B315E Rev. C

Chips
Produced by Medtronic for
Distribution by BioHorizons Implant
Systems, Inc.

2018-06-20

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 human bone tissue recovered in the USA 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 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, single 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 other
processing 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 proceeding sections), 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 BioHorizons, Inc. or 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 United States 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
HTLV I/II Human T-lymphotrophic virus types I and II
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). Nucleic Acid Amplification Testing
(NAT) for HBV was performed for donors recovered after December 21, 2015. 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/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” and/or European Commission Directive 2006/17/EC including
amendments and European national transpositions when additional serological testing is required for deceased donors, 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 tissue allograft product was released by Medtronic based on the initial donor eligibility determination and on a post­processing review and determination that the product 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 in
the proceeding sections. 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 in the
following sections.

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 produced by Medtronic bears a lot or serial number that serves as a
distinct identification code recorded in Medtronic and BioHorizons 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 used, it should be disposed of properly. Document the reason for the graft not
being used.

For European Economic Area audience only: these tissue tracking records shall be maintained for 30 years after clinical use. In
case product traceability to recipient is at risk, the customer shall secure the transfer of the records to another entity (preferably
a Tissue Establishment or Organ Bank) in order to secure continued traceability. BioHorizons shall be informed of such a
transfer of records.

This traceability will be extended by the recording in the patients records of the Single European Code, applied on the product
as of 29 April 2017, as required by COMMISSION DIRECTIVE (EU) 2015/565 and COMMISSION DIRECTIVE (EU) 2015/566.

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.

If any of the above conditions exist or are suspected, this allograft should not be used.

GENERAL INSTRUCTIONS

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 Glass Bottles

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.

STORAGE

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.

RETURNS

For any returns deemed necessary as a result of an error by BioHorizons Implant Systems, Inc. or Medtronic or a product
complaint, a Return Authorization Number is required from BioHorizons prior to shipping. Full credit or replacement product will
be issued.

For European Economic Area audience only: the customer shall notify serious adverse events (any untoward occurrence
associated with the procurement, testing, processing, storage, and distribution of tissues and cells that might lead to the
transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions for patients or which
might result in, or prolong, hospitalization or morbidity) or serious adverse reactions (an unintended response, including a
communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and
cells that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalization or morbidity) within 1
day to their local BioHorizons representative.

MRI INFORMATION

MR Safe
MinerOss™ Tissue is MR Safe.
MinerOss™ 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, the MinerOss™ Tissue is not susceptible
to heating due to Radio Frequency (RF) fields. As such, MinerOss™ 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.
CTO Registration # 100138 (Canada)

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)

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

DISTRIBUTED BY:

BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham, Alabama, USA 35244

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

DESCRIPTION OF DEVICE MARKINGS

15 °C

30 °C

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

Consult instructions for use

Do Not Re-use

Use-by date

Batch code

Catalogue number

Temperature limit

Sterilized using aseptic processing techniques

Manufacturer

Date of Manufacture

Do not use if package is damaged

MR Safe