Medtronic 6100-020 Instructions for Use

WARNING

Do not use this product if packaging has been opened or damaged.

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. 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 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 certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U .S.C.
263a) and 42 CFR 493, using FDA licensed 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 I and 2

• RPR/STS or Equivalent Syphilis Detection

In addition to the above tests, donors recovered prior to March 9, 2005, were tested for HIV-I 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 I/
Nucleic Acid Amplification Testing (HIVI 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. 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 1270 “Human Tissue Intended for Transplantation” and/or 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,
Edmond, OK 73013

Musculoskeletal Transplant Foundation,
Edison, NJ 08837

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 and are available upon request.

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

VIRAL INACTIVATION

In the production of PLEXUR M® , the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis Band C and CMV.

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
PLEXUR M unit distributed by Medtronic bears a lot number and serial number that serve as a distinct identification code and are recorded in Medtronic’s distribution records
for purposes of tracking the tissue to the consignee or user/tissue transplant facility. The lot number and 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:

I. Description of Tissue

2. Lot Number (Donor ID)

3. Product Code

4. Expiration Date

5. Quantity Implanted

6. Antibiotics Used

7. Description of Procedure

8. Date and Time of Procedure

PLEXUR M® M708348B349 Rev. A

M708348B349E Rev. B

IMPORTANT INFORMATION ON PLEXUR M®

2013-05-29

Medtronic Sofamor Danek USA, Inc. SpinalGraft Technologies LLC

Memphis, TN 38132 Suite 39
Telephone [phone] (In U.S.A.) Memphis, TN 38118
901 396 3133 (Outside U.S.A.)
Fax [phone]

ENGLISH

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, SlNGLE PROCEDURE ONLY

CAUTION: RESTRICTED TO USE BY A PHYSICIAN

NO ADDITIONAL STERILIZATION STEP IS TO BE PERFORMED BY THE USER

DO NOT USE IF THE PACKAGE IS DAMAGED

1800 Pyramid Place 4340 Swinnea Road

IMPORTANT INFORMATION ON PLEXUR M®

DESCRIPTION

PLEXUR M® is a tissue allograft product manufactured using a composite of nondemineralized bone fibers and resorbable polymers. This product is supplied sterile for single
patient use. PLEXUR M® is provided in a solid form that is intended to be heated at the time of use to render it moldable to facilitate its placement by the surgeon at the
implant site. Upon cooling and at body temperature, PLEXUR M® returns to its natural, hard state.

DISTRIBUTED BY:

This product contains human bone tissue recovered from a cadaveric donor using aseptic surgical techniques and microbiologically tested during recovery. The tissue was
further processed under aseptic conditions and was treated with antibiotics (gentamicin). The final product, in packaged form, was sterilized using gamma irradiation.
Medtronic may also use low dose gamma irradiation as an adjunct to aseptic processing of the cadaver bone to reduce the starting bioburden. Each PLEXUR M® final product
lot was tested for endotoxins using a qualified test method.

PLEXUR M® is packaged in ready-to-use form in single patient use containers. The lot number and/or serial number, expiration date, product code, quantity (volume or
size), and additional information are listed on the package label.

INDICATIONS

PLEXUR M® is intended for use in filling bony voids or gaps of the skeletal system (i.e. extremities, pelvis) that are not intrinsic to the stability of the bony structure. These
defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone or other bony defects. PLEXUR M® may be used in conjunction
with autograft in the spine. PLEXUR M® is resorbed/remodeled and is replaced by host bone during the healing process.

CONTRAINDICATIONS

PLEXUR M® is not intended to provide structural support during the healing process; therefore, PLEXUR M® is contraindicated where the product is intended as structural
support in the skeletal system.

RELATIVE CONTRAINDICATIONS

• Severe vascular or neurological disease

• Uncontrolled diabetes

• Severe degenerative bone disease

• Pregnancy

• Presence of infection at the site

• Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol

• Hypercalcemia

ADVERSE EFFECTS

Possible adverse effects include but are not limited to:

• Wound complications, as possible with any surgery, such as hematoma, site drainage, infection, and bone fracture

• Fracture or extrusion of PLEXUR M® Bone Void Filler with or without side effects

• Deformity of the bone at the site

• Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone void filler

Medtronic Sofamor Danek USA, Inc. SpinalGraft Technologies LLC

1800 Pyramid Place 4340 Swinnea Road
Memphis, TN 38132 Suite 39
Telephone [phone] (In U.S.A.) Memphis, TN 38118
901 396 3133 (Outside U.S.A.)
Fax [phone]

IMPORTANT INFORMATION ON PLEXUR M®

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, SlNGLE PROCEDURE ONLY

CAUTION: RESTRICTED TO USE BY A PHYSICIAN

NO ADDITIONAL STERILIZATION STEP IS TO BE PERFORMED BY THE USER

DO NOT USE IF THE PACKAGE IS DAMAGED

DESCRIPTION

PLEXUR M® is a tissue allograft product manufactured using a composite of nondemineralized bone fibers and resorbable polymers. This product is supplied sterile for single
patient use. PLEXUR M® is provided in a solid form that is intended to be heated at the time of use to render it moldable to facilitate its placement by the surgeon at the
implant site. Upon cooling and at body temperature, PLEXUR M® returns to its natural, hard state.

This product contains human bone tissue recovered from a cadaveric donor using aseptic surgical techniques and microbiologically tested during recovery. The tissue was
further processed under aseptic conditions and was treated with antibiotics (gentamicin). The final product, in packaged form, was sterilized using gamma irradiation.
Medtronic may also use low dose gamma irradiation as an adjunct to aseptic processing of the cadaver bone to reduce the starting bioburden. Each PLEXUR M® final product
lot was tested for endotoxins using a qualified test method.

PLEXUR M® is packaged in ready-to-use form in single patient use containers. The lot number and/or serial number, expiration date, product code, quantity (volume or
size), and additional information are listed on the package label.

INDICATIONS

PLEXUR M® is intended for use in filling bony voids or gaps of the skeletal system (i.e. extremities, pelvis) that are not intrinsic to the stability of the bony structure. These
defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone or other bony defects. PLEXUR M® may be used in conjunction
with autograft in the spine. PLEXUR M® is resorbed/remodeled and is replaced by host bone during the healing process.

CONTRAINDICATIONS

PLEXUR M® is not intended to provide structural support during the healing process; therefore, PLEXUR M® is contraindicated where the product is intended as structural
support in the skeletal system.

RELATIVE CONTRAINDICATIONS

• Severe vascular or neurological disease

• Uncontrolled diabetes

• Severe degenerative bone disease

• Pregnancy

• Presence of infection at the site

• Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol

• Hypercalcemia

ADVERSE EFFECTS

Possible adverse effects include but are not limited to:

• Wound complications, as possible with any surgery, such as hematoma, site drainage, infection, and bone fracture

• Fracture or extrusion of PLEXUR M® Bone Void Filler with or without side effects

• Deformity of the bone at the site

• Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone void filler

WARNING AND PRECAUTIONS

of tissues in accordance with current FDA regulations and standards established by the American Association of Tissue Banks. 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 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 certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U .S.C.
263a) and 42 CFR 493, using FDA licensed 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 I and 2

• RPR/STS or Equivalent Syphilis Detection

In addition to the above tests, donors recovered prior to March 9, 2005, were tested for HIV-I 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 I/
Nucleic Acid Amplification Testing (HIVI 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. 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 1270 “Human Tissue Intended for Transplantation” and/or 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,
Edmond, OK 73013

Musculoskeletal Transplant Foundation,
Edison, NJ 08837

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 and are available upon request.

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

VIRAL INACTIVATION

In the production of PLEXUR M® , the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis Band C and CMV.

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
PLEXUR M unit distributed by Medtronic bears a lot number and serial number that serve as a distinct identification code and are recorded in Medtronic’s distribution records
for purposes of tracking the tissue to the consignee or user/tissue transplant facility. The lot number and 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:

I. Description of Tissue

2. Lot Number (Donor ID)

3. Product Code

4. Expiration Date

5. Quantity Implanted

6. Antibiotics Used

7. Description of Procedure

8. Date and Time of Procedure

9. Surgeon Name

10. Any Other Pertinent Information

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. Medtronic
BV shall be informed of such a transfer of records.

HANDLING AND USE

PLEXUR M® is provided sterile and should be considered sterile unless the packaging has been opened or damaged. This product should not be resterilized. All product
heating and handling must occur in the sterile field. Strict adherence to aseptic practices must be followed during the surgical procedure to prevent product contamination.

ENGLISH

2013-05-29

DISTRIBUTED BY:

As with any surgical procedure, care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure. This includes
individuals with bleeding disorders of any etiology, long-term steroidal therapy or immunosuppressive therapy.

Use this product as supplied and according to the HANDLING AND USE information provided. Do not heat PLEXUR M® using a method not described in these instructions.

Adequate fixation should be used to stabilize the implant site during hone formation and healing.

Despite the extensive tissue donor selection and qualification processes used in providing the tissue for this product, transmission of an infectious disease through the use of this
tissue is still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially attributable to PLEXUR M® must be reported promptly to Medtronic.

WARNING

Do not use this product if packaging has been opened or damaged.

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. 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 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 certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U .S.C.
263a) and 42 CFR 493, using FDA licensed 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 I and 2

• RPR/STS or Equivalent Syphilis Detection

In addition to the above tests, donors recovered prior to March 9, 2005, were tested for HIV-I 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 I/
Nucleic Acid Amplification Testing (HIVI 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. 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 1270 “Human Tissue Intended for Transplantation” and/or 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,
Edmond, OK 73013

Musculoskeletal Transplant Foundation,
Edison, NJ 08837

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 and are available upon request.

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

VIRAL INACTIVATION

In the production of PLEXUR M® , the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis Band C and CMV.