Medtronic T50303 Instructions for Use

Grafton™ DBF Demineralized Bone

M708348B464E Rev. E

Matrix (DBM) Fibers Family of
Products

2021-08-24

IMPORTANT INFORMATION ON THE GRAFTON™ DBF DEMINERALIZED BONE
MATRIX (DBM) FIBERS FAMILY OF PRODUCTS

READ BEFORE USE

This graft is derived from human tissue which was generously donated so others may benefit.
Each unit is intended for single patient, single use only.
Caution: restricted to use by a physician, podiatrist, or dentist.
No additional sterilization step is to be performed.

DESCRIPTION

Grafton™ DBF is comprised of banked human bone tissue that was 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 treated with antibiotics (gentamicin), cleaned using 70% alcohol,
washed with purified water, and sonicated. Subsequent demineralization of the bone tissue (using the D-MIN™ proprietary
demineralization process) to produce the DBM in this product was performed so the resulting bone matrix has a calcium content
level that meets current American Association of Tissue Banks (AATB) standards.

Grafton™ DBF includes demineralized bone allograft fibers that are osteoconductive as well as osteoinductive in an athymic rat
assay.

Grafton™ DBF is prepared via a proprietary processing method of Medtronic validated to consistently produce DBM that is
osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of Grafton™ DBF
finished product for osteoinductivity in this validated athymic rat assay using a five-point linear scale (0,1,2,3,4) to score bone
formation at 28 days post implantation*. This bone forming activity exhibited by Grafton™ DBF in this athymic rat surrogate
assay should not be interpreted as a predictor of clinical performance.

*Edwards, J.T., PhD, Diegmann, M.H., MS, Scarborough, N.L., PhD.: Osteoinduction of Human Demineralized Bone:
Characterization in a Rat Model. Clinical Orthopaedics, December, 1998, Vol 357.

INDICATIONS

Grafton™ DBF 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.

STERILITY

Grafton™ DBF is labeled as “Aseptically Processed, Passes USP Sterility Tests” or “Sterile” which means it was aseptically
processed and tested for sterility according to procedures in the current US Pharmacopeia. When explanting and/or disposing of
a product, be sure to avoid exposure to bodily substances such as blood, tissue, etc., as contact could lead to infection or
disease. Always wear and use proper equipment, taking special care with sharp objects and needles. Follow your healthcare
center’s policy regarding both the disposal of devices and any events of exposure.

PRETREATMENT WITH LOW-DOSE GAMMA IRRADIATION

Medtronic may use low dose gamma irradiation as an adjunct to aseptic processing to reduce bioburden. Labels containing
“Treated with Gamma Irradiation” indicate low dose (1.0-1.8 Mrad) gamma irradiation was used to reduce bioburden on donor
tissue.

POTENTIAL ADVERSE EVENTS

Donor screening methods are limited. Therefore, certain diseases may not be detected. The following complications of tissue
transplantation may occur:

▪ Transmission or causation of diseases of unknown etiology and characteristics.
▪ Transmission of known infectious agents including HIV, Hepatitis B, Hepatitis C, syphilis, and bacteria.
▪ Immune rejection of transplanted grafts.
▪ Loss of function or integrity of transplanted tissue due to resorption, fragmentation, or disintegration including associated

loss of continuity, displacement, bending, or fracture.

All of the same medical/surgical conditions that may complicate any surgical procedure may occur during or following
transplantation of an allograft. Adverse outcomes potentially attributable to Grafton DBF must be promptly reported to Medtronic
at [phone] or [phone].

CAUTION

This allograft may contain trace amounts of antibiotics (gentamicin), antiseptic (povidone-iodine) and alcohol solutions. Caution
should be exercised if the patient is allergic to these antibiotics or chemicals. This device was designed for single patient use
only. Do not reprocess or reuse this product. Reuse or reprocessing may compromise the structural integrity of the device
and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

PRECAUTIONS

Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing were
used to qualify tissue donors. Despite the viral inactivation and extensive tissue donor selection and qualification processes
used in providing this tissue graft (see DONOR SCREENING AND TESTING), transmission of communicable disease is still
possible. Bacterial infection at the graft site may also occur.

If injecting Grafton™ DBF into the defect site, precaution should be taken not to:

▪ over-pressurize the delivery device, as this may lead to extrusion of the device beyond the site of its intended application

and damage to the surrounding tissues.

▪ over-pressurize the defect site, as this may lead to fat embolization or embolization of the device material into the

bloodstream.

CONTRAINDICATIONS

The presence of infection at the implantation 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 FDA regulations and standards established by
the AATB. The donor’s medical/social history was also screened for HIV, Hepatitis, and CJD/vCJD high risk factors in
accordance with 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)
▪ HTLV I/II (Human T-lymphotrophic virus types I and II)
▪ HBV NAT (Hepatitis B virus nucleic acid amplification testing)

Results of relevant communicable disease tests referenced were negative or non-reactive.
In addition to the tests listed, other tests may have been performed including WNV NAT (West Nile Virus nucleic acid

amplification testing).
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 were evaluated. Based
on this evaluation, the donor met donor eligibility criteria current at the time of recovery. Donor eligibility criteria used to screen
donors are in compliance with FDA regulations published in 21 CFR Part 1270 and/or Part 1271.

Donor eligibility was determined by one of the following tissue banks:
American Tissue Services Foundation

Glendale, AZ 85303
Community Tissue Services

Dayton, OH 45402
LifeNet Health

Virginia Beach, VA 23453
RTI Surgical, Inc.

Alachua, FL 32615
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 eligibility of this human tissue are on file at Medtronic, Eatontown, NJ and available upon request.

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

This tissue allograft product was released for transplantation.

TISSUE TRACKING

Federal (USA) regulations under 21 CFR 1271 establish requirements for tracking human tissue. 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 recorded in Medtronic’s distribution records to track the tissue to the consignee or user/tissue transplant
facility. This lot or serial number should be recorded on the provided tissue tracking record (TTR), in the user/tissue transplant
facility’s records, and in the tissue recipient's medical record, along with the following:

1. 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. Other pertinent information

PREPARATION FOR USE

Grafton™ DBF should be hydrated with either blood, bone marrow aspirate, sterile saline, or sterile water prior to implantation.
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 clinician. Reconstituted product must be used within the time allocated for the
surgical procedure.

If the graft is opened and not used, it should be disposed of properly or returned to Medtronic. Document the reason for not
using the graft on the Tissue Tracking Record and return the Tissue Tracking Record to Medtronic.

Examine allograft package before use. Do not use this allograft if:

▪ Package materials or contents appear to be missing, tampered with, or damaged.
▪ Package label or identifying bar code is illegible or missing.
▪ Expiration date shown on the package label has passed.
▪ Any of the above conditions exist or are suspected.

Note: once a package seal is broken, the tissue should be either transplanted, if appropriate, or otherwise discarded. Empty or
partially used allograft containers should be disposed of in accordance with recognized procedures for discarding medical waste
material.

Opening Instructions for Grafton™ DBF

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

2. Pass sterile contents into sterile field.

Opening Instructions for disposable graft loading Cannulas

1. Peel open the single barrier tray using proper sterile technique

2. Pass sterile contents into sterile field.

3. Retrieve graft loading tubes from inner packaging.

4. See graft delivery guide instructions for use of loading tubes and graft delivery instruments.

Opening Instructions for Grafton™ DBF Fibers (Jar Configuration)

1. Peel open inner pouch to access the Grafton™ DBF jar

2. To access the Grafton™ DBF tissue, unscrew the jar lid.

Use product that is hydrated* according to the hydration volumes in the table below. Product might require kneading/manual
manipulation of the graft during soaking to ensure full hydration. Handling characteristics can be varied by adjusting hydration
volume. When Grafton™ DBF is hydrated or used in combination with autologous bone tissues, other forms of allografts, or
other bone grafting materials, remove any excess fluids (including rehydration solution) from these graft materials before the
other grafts come into contact with Grafton™ DBF.

Grafton™ DBF Size Hydration Volume

1cc 0.5cc
3cc 1.5cc
6cc 3cc
9cc 7cc
12cc 9.5cc

Opening Instructions for MIS Cannula Accessory Kit (Syringe Configuration)

1. Open carton containing the MIS Cannula Accessory Kit.

2. Follow Instructions for Use document contained within the MIS Cannula Accessory Kit for proper opening.

Opening Instructions for Grafton™ DBF Inject (Syringe Configuration)

Graphical preparation steps are provided on the syringe foil pouch.

1. Draw appropriate volume of fluid* (according to table below) with standard male luer lock syringe (not provided). Handling or
delivery characteristics can be varied by adjusting hydration volume.

Grafton™ DBF Inject Size Hydration Volume

3cc 3.5cc
6cc 6.5cc
9cc 9.5cc

2. Open pre-filled syringe foil pouch to reveal product.

3. Remove Cap Plug (red) from Hydration Adapter on pre-filled syringe. Ensure Hydration Adapter remains tightly connected

to syringe.

4. Position Syringe and Hydration Adapter vertically with the Hydration Adapter pointing up so fluid flows down into graft.
Hydrate graft material with standard male luer lock syringe prepared in step 1. Note: some fluid may vent at the Hydration
Adapter interface with syringe.

5. Remove both standard male luer lock syringe and Hydration Adapter.

6. Obtain Thread Cap Plug (blue) from the supplied MIS Cannula Accessory Kit. Tighten cap onto Tapered End Cap of the

pre-filled syringe. Ensure Tapered End Cap remains tightly connected to syringe.

7. Position syringe with Thread Cap Plug (blue) pointing down. Pump the Plunger Body ≥30 times to ensure consistent
hydration of graft.

8. Remove Cap Plug (blue) from Tapered End Cap of the pre-filled syringe. Ensure Tapered End Cap remains tightly
connected to syringe.

9. Thread Cannula of choice from the supplied MIS Cannula Accessory Kit onto Tapered End Cap.

10. Depress (push) Plunger Body to dispense material to surgical site.

11. Thread appropriate Proximal Stylet (based on cannula choice in step 9) onto Distal Stylet.

12. Depress (push) Stylet through the Cannula to deliver material in the Cannula to the surgical site.

13. Use Secondary Thumb Tab to deliver remaining material to the surgical site.

*Addition of antibiotics of choice is optional

VISUAL INSPECTION

Visually inspect all sterile-barrier packaging before use. If the sterile barrier is damaged or the integrity is compromised, do not
use. Contact Medtronic for return information. Visually inspect the product before use. If the product is damaged, do not use.
Contact Medtronic for return information.

PACKAGING

Devices are supplied sterile. Sterile means it was aseptically processed and tested for sterility according to procedures in the
US Pharmacopeia. Packages for components should be intact upon receipt. Once the seal on the sterile package is broken, the
product should not be re-sterilized. If a loaner set is used, all sets and components should be carefully checked for
completeness and to ensure there is no damage prior to use. Damaged packages or products should not be used and should
be returned to Medtronic.

STORAGE

See package label for specific storage conditions. It is the responsibility of the transplant facility or clinician to maintain 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 Medtronic, or a product complaint, a Return Authorization Number
is required from Medtronic prior to return. Full credit will be issued. For returns other than an error by Medtronic or a product
complaint, refer to Medtronic’s Return Policy.

REFERENCES

Standards for Tissue Banking (current version), American Association of Tissue
Banks, McLean, VA. Current Policies and Procedures of Medtronic, Eatontown, N.J.
FDA Final Rule for “Eligibility Determination for Donors of Human Cell, Tissue and Cellular and Tissue Based Products”, 21

CFR, Parts 210, 211, 820 and 1271, Federal Register, May 25, 2004 (Volume 69. Number 101) pg. 29785 – 29834.
FDA Final Rule for “Current Good Tissue Practice for Donors of Human Cell, Tissue and Cellular and Tissue-Based Products”,

21 CFR Parts 16, 1271, Federal Register, November 24, 2004 (Volume 69, Number 226) pg 68611- 68688.
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,” 01/31/20.

MRI INFORMATION

MR Safe
Grafton™ DBF is MR Safe.
Grafton™ DBF 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, Grafton™ DBF is not susceptible to
heating due to RF (radio frequency) fields. As such, Grafton™ DBF can justifiably be labeled as MR- Safe per ASTM F2503.

If Grafton™ DBF is used in connection with any device which is not MR Conditional, be advised this combination was not tested
in the MR environment and, therefore, higher heating and possible injury to the patient may occur.

PRODUCT COMPLAINTS

For product problems, contact Medtronic.

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.

©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.

DISTRIBUTED BY:

SpinalGraft™ Technologies LLC
4340 Swinnea Road, Suite 39
Memphis, TN 38118

EXPLANATION OF SYMBOLS

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

15 °C

30 °C

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

Temperature limit

Do not re-use

Manufacturer

Date of manufacture

Catalogue number

For US audiences only

Sterilized using aseptic processing techniques

Use-by date

Consult instructions for use

Do not use if package is damaged and consult instructions
for use

MR Safe

Serial Number

Contains biological material of human origin

*Single sterile barrier system

Double sterile barrier system

Single sterile barrier system with protective packaging
inside

Single sterile barrier system with protective packaging
outside

*Single barrier packaging systems may not contain a
sterile barrier system symbol. Per ISO 11607-1, a symbol
is only required if more than one barrier is present.