Medtronic T00962 Instructions for Use

M708348B354 Rev. A

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 by
laboratories 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 licensed 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

In addition to the tests mentioned, donors recovered prior to March 9, 2005, were
tested for HIV-1 by p24 antigen testing or DNA Polymerase Chain Reaction (PCR) or
Transcription Mediated Amplification (TMA) Nucleic Acid Amplification Testing (NAT).
Donors recovered after March 9, 2005, were tested using Human Immunodeficiency
Virus Type 1/Nucleic Acid Amplification Testing (HIV1 NAT) and Hepatitis C Virus/
Nucleic Acid Amplification Testing (HCV NAT). Donors may or may not be tested for
HTLV I/II (Human T-Lymphotropic Virus Types I and II).

The results of all the relevant communicable disease tests referenced above were
found to be negative.

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,
Edmond, OK 73013

Community Tissue Services,
Dayton, OH 45402

LifeNet Health,
Virginia Beach, VA 23453

RTI Biologics
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, Inc and are
available upon request.

The final, processed tissue allograft was released by Medtronic, Inc., based on the initial

M708348B354E Rev. A

MinerOss®

Cortical & Cancellous Chips (US Only)

Produced by Medtronic, Inc. for

Distribution by BioHorizons Implant Systems, Inc.

®

Important Package Insert and Rehydration Information for MinerOss

DISTRIBUTED BY:

Memphis, Tennessee 38132 Suite 39
Telephone: [phone] (in USA) Memphis, TN 38118
901 396 3133 (outside USA)
Fax: [phone]

2012-10-03

Medtronic Sofamor Danek USA, Inc. SpinalGraft Technologies LLC

1800 Pyramid Place 4340 Swinnea Road

Read Before Use

THIS ALLOGRAFT IS DERIVED FROM HUMAN TISSUE WHICH WAS GENEROUSLY

Cortical & Cancellous Chips

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.

ENGLISH

IMPORTANT INFORMATION ON MINEROSS® Cortical & Cancellous Chips

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 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.

IMPORTANT INFORMATION ON MINEROSS® Cortical & Cancellous Chips

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 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

Donor eligibility was determined by one of the following tissue banks:

American Tissue Services Foundation,
Edmond, OK 73013

Community Tissue Services,
Dayton, OH 45402

LifeNet Health,
Virginia Beach, VA 23453

RTI Biologics
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, Inc and are
available upon request.

The final, processed tissue allograft was released by Medtronic, Inc., based on the initial
donor eligibility determination and on a post-processing review and determination that
the allograft met all processing requirements and allograft specifications.

This tissue has been released for transplantation.

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.

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, Inc. may use low dose gamma irradiation as an adjunct to aseptic
processing to reduce bioburden as described in the proceeding 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, Inc. bears a lot or serial number that serves
as a distinct identification code that is recorded in Medtronic’s 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:

ENGLISH

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, Inc.

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 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 United States 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 by
laboratories 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 licensed 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

In addition to the tests mentioned, donors recovered prior to March 9, 2005, were
tested for HIV-1 by p24 antigen testing or DNA Polymerase Chain Reaction (PCR) or
Transcription Mediated Amplification (TMA) Nucleic Acid Amplification Testing (NAT).

HCV Hepatitis C Antibody
HIV 1/2-Ab Antibody to Human Immunodeficiency Virus Types 1 and 2
RPR/STS or Equivalent Syphilis Detection

In addition to the tests mentioned, donors recovered prior to March 9, 2005, were
tested for HIV-1 by p24 antigen testing or DNA Polymerase Chain Reaction (PCR) or
Transcription Mediated Amplification (TMA) Nucleic Acid Amplification Testing (NAT).
Donors recovered after March 9, 2005, were tested using Human Immunodeficiency

Virus Type 1/Nucleic Acid Amplification Testing (HIV1 NAT) and Hepatitis C Virus/
Nucleic Acid Amplification Testing (HCV NAT). Donors may or may not be tested for
HTLV I/II (Human T-Lymphotropic Virus Types I and II).

The results of all the relevant communicable disease tests referenced above were
found to be negative.

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,
Edmond, OK 73013

Community Tissue Services,
Dayton, OH 45402

LifeNet Health,
Virginia Beach, VA 23453

RTI Biologics
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, Inc and are
available upon request.

The final, processed tissue allograft was released by Medtronic, Inc., based on the initial
donor eligibility determination and on a post-processing review and determination that
the allograft met all processing requirements and allograft specifications.

This tissue has been released for transplantation.

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.

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.

Donor eligibility was determined by one of the following tissue banks:

American Tissue Services Foundation,
Edmond, OK 73013

Community Tissue Services,
Dayton, OH 45402

LifeNet Health,
Virginia Beach, VA 23453

RTI Biologics
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, Inc and are
available upon request.

The final, processed tissue allograft was released by Medtronic, Inc., based on the initial
donor eligibility determination and on a post-processing review and determination that
the allograft met all processing requirements and allograft specifications.

This tissue has been released for transplantation.

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.

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

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.
# 100138 (Canada)

Printed in U.S.A.

PROCESSED ALLOGRAFT TISSUE

©2012 Medtronic Sofamor Danek USA, INC. All rights reserved.

R

only

aseptically processed and then tested for sterility according to the procedures in the
current U.S. Pharmacopeia.

treatment with Low-Dose gamma irraDiation

Medtronic, Inc. may use low dose gamma irradiation as an adjunct to aseptic
processing to reduce bioburden as described in the proceeding 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, Inc. bears a lot or serial number that serves
as a distinct identification code that is recorded in Medtronic’s 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 6. Antibiotics Used

2. Lot Number (Donor ID) 7. Description of Procedure

3. Product Code 8. Date and Time of Procedure

4. Expiration Date 9. Surgeon Name

5. Quantity Implanted 10. Any Other Pertinent Information

If for any reason the graft is opened and not utilized, it should be disposed of properly.
Document the reason for the graft not being utilized.

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.

R

only

LOT

REF

15°C

15°C to 30°C

STERILE A

STERILE R

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.

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, Inc. or
Medtronic, Inc. or a product complaint, a Return Authorization Number is required from
BioHorizons, Inc. 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

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.

If MinerOss® Cortical and Cancellous Chips 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.

R

LOT

REF

15°C

15°C to 30°C

STERILE A

MR

SN

STERILE R

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.

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, Inc. or
Medtronic, Inc. or a product complaint, a Return Authorization Number is required from
BioHorizons, Inc. 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

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.

If MinerOss® Cortical and Cancellous Chips 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

1. Standards for Tissue Banking (current version), American Association of Tissue
Banks, Arlington, VA.

2. Current Policies and Procedures of Medtronic, Inc.

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.
# 100138 (Canada)

CTO Registration

Printed in U.S.A.

PROCESSED ALLOGRAFT TISSUE

©2012 Medtronic Sofamor Danek USA, INC. All rights reserved.

Printed in U.S.A.

PROCESSED ALLOGRAFT TISSUE

©2012 Medtronic Sofamor Danek USA, INC. All rights reserved.

R

REF

only

LOT

DESCRIPTION of DEVICE MARKINGS

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

Consult Instructions for Use

Do not reuse.

Use by

Batch code

15°C

15°C to 30°C

STERILE A

STERILE R

Catalogue Number

30°C

Temperature Limit

Sterile Using Aseptic Processing Techniques

Sterilized Using Irradiation

Manufacturer

Do Not Use if Package is Damaged

MR

SN

MR Safe

Serial Number