Medtronic 7509141INT Instructions for Use

Magnifuse™ Bone Graft M708348B245E Rev. E

2022-07-01

IMPORTANT INFORMATION ON MAGNIFUSE™ BONE GRAFT

Note: not all parts may be available in each geography.

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 procedure only.
Caution: restricted to use by a physician.
No additional sterilization step is to be performed.

DESCRIPTION

Magnifuse™ Bone Graft is comprised of human bone allograft tissue matrix in a resorbable mesh pouch to yield a high­performance allograft product having a particular physical form and handling property. No additional carrier is added to the
allograft material.

Magnifuse™ Bone Graft was prepared from human bone tissue recovered in the USA from a cadaveric donor using aseptic
surgical techniques and microbiologically tested during recovery. The tissue was further processed under aseptic conditions and
exported from the USA. The tissue was 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. Subsequent demineralization
of bone tissue (using the D-MIN™ proprietary demineralization process) to produce 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.
Bone chips are surface demineralized. Tissue components were sealed in a resorbable mesh pouch to form the final allograft
product. As a biological material, some variations in the product should be expected in both handling and appearance. The final
product in packaged form was tested for sterility according to procedures in the current US Pharmacopoeia.

Magnifuse™ Bone Graft is a bone allograft product that is osteoinductive as well as osteoconductive in a validated athymic rat
assay.

Process consistency is confirmed via ongoing testing of Magnifuse™ Bone Graft finished product for osteoinductivity in this
athymic rat assay using a five-point linear scale (0,1,2,3,4) to score bone formation at 28 days post implantation*. Bone forming
activity exhibited by Magnifuse™ Bone Graft 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, Volume 357.

Magnifuse™ Bone Graft is packaged in a ready to use form, in single patient use containers. Lot number and/or serial number,
expiration date, product code, quantity (volume or size), and additional information are listed on the package label.

The device lifetime for Magnifuse™ Bone Graft is two years in which it is expected to achieve its performance and maintain its
safety.

For US audiences only

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

VIRAL INACTIVATION PROCEDURES

Magnifuse™ Bone Graft is produced by processing steps validated or shown to inactivate viruses including HIV-1, hepatitis B
(duck hepatitis virus as model), hepatitis C (bovine diarrhea virus as model), CMV, and Polio.* Testing was performed according
to current concepts and study design elements for process validation studies for removal and/or inactivation of viruses in
production of biopharmaceutical products recommended by the Food and Drug Administration’s (FDA) Center for Biologics

Evaluation and Research
Good Laboratory Practice for Nonclinical Laboratory Studies regulations stated in the Code of Federal Regulations (21 CFR §

58).
These viral inactivation procedures were used to reduce risk of disease transmission via use of this allograft beyond protection

provided by donor testing and screening.
*Data on file at Medtronic.

1, 2, 3

and the European community

4, 5, 6, 7

. All studies were performed in certified conformity with

INDICATIONS

Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e. spine,
pelvis, and extremities) not intrinsic to stability of bony structure. Voids or gaps may be surgically created defects or defects
created by traumatic injury to bone.

Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft
may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile saline to adjust consistency and handling
of bone graft material. Magnifuse™ Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

CONTRAINDICATIONS

▪ Presence of infection at the transplantation site.
▪ Treatment of spinal insufficiency fractures.

POTENTIAL ADVERSE EVENTS

All adverse events associated with spinal fusion surgery without instrumentation are possible. 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.

With instrumentation, a listing of potential adverse events includes:

▪ Early or late loosening of components.
▪ Disassembly, bending, or breakage of components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, or general corrosion) including

metallosis, staining, tumor formation, or autoimmune disease.

▪ Pressure on skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin

penetration, irritation, fibrosis, necrosis, or pain.

CAUTION

This product may contain trace amounts of antibiotics (gentamicin), antiseptic (povidone-iodine), surfactant, and other
processing solutions used in processing bone tissue as well as mesh. 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 were
used in the qualification of tissue donors. Despite viral inactivation and extensive tissue donor selection and qualification
processes used in providing this tissue graft, transmission of infectious disease through use of tissue graft is still possible.
Bacterial infection at the graft site may also occur. Adverse outcomes potentially attributable to Magnifuse™ Bone Graft must be
reported promptly to Medtronic.

Adequate fixation should be used to stabilize the implant site during bone formation and healing in bony voids or gaps of the
skeletal system.

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 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 and Hepatitis 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-Lymphotropic Virus Types I & II

Results of relevant infectious disease tests referenced were found to be negative or non-reactive.
In addition to the tests listed, other tests may have been performed including tests for HBV NAT (Hepatitis B virus NAT) and

WNV NAT (West Nile Virus NAT). NAT for HBV was performed for donors recovered after December 21, 2015 and in those
cases where the donor’s tissue is distributed to a country requiring such testing. If HBV NAT and WNV NAT were performed,
results were negative or non-reactive, and results of any other tests performed were negative or otherwise acceptable for
eligibility of donors of musculoskeletal tissues.

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
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

Glendale, AZ 85303
Community Tissue Services

Dayton, OH 45402
LifeNet Health

Virginia Beach, VA 23453
RTI Surgical, Inc.

Alachua, FL 32615
Musculoskeletal Transplant Foundation

Edison, NJ 08837
Aziyo Biologics Inc.

Richmond, CA 94804
AlloSource

Centennial, CO 80111
Names and addresses of testing laboratories, the listing and interpretation of all required communicable disease tests, a listing

of documents reviewed as part of 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 are available upon request.

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

This tissue allograft was released for transplantation.

STERILITY

Magnifuse™ Bone Graft products were aseptically processed and tested for sterility according to the procedures in the US
Pharmacopeia, as indicated by the package label.

When explanting and/or disposing of a device, 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 (1.0–1.8Mrad) gamma irradiation was used as a means of reducing
bioburden on donor tissue.

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 Magnifuse™ Bone Graft unit distributed by Medtronic bears a lot number that serves as a
distinct identification code recorded in Medtronic’s distribution records for tracking tissue to the consignee or user/tissue
transplant facility. This lot number should be recorded 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

If the graft is opened and not used, it should be disposed of properly or returned to Medtronic. Document the reason for the graft
not being used.

For European Economic Area audience only: these tissue tracking records will be maintained for 30 years after clinical use. In
case product traceability to recipient is at risk, the customer will secure the transfer of the records to another entity (preferably a
tissue establishment or organ bank) to secure continued traceability. Medtronic BV will be informed of such a transfer of
records. This traceability will be extended by the recording 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. Other pertinent information

INSTRUCTIONS FOR USE

Do not use contents of any package for multiple patients. Empty or partially used packages should be disposed of in
accordance with recognized procedures for discarding medical waste materials.

Before use, examine product package. Do not use if:

1. Package materials or contents appear to be missing, tampered with, or damaged.

2. Package label or identifying bar code is illegible or missing.

3. Expiration date shown on the package label has passed.

4. Any of the above conditions exist or are suspected.

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
tracing tissue/recipient information in the unlikely event of suspected or actual transmission of disease and allowing appropriate
actions.

Note: once a package seal is broken, the tissue should be either transplanted, if appropriate, or 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 sterile contents to sterile field.

3.

In the sterile field, open the inner foil pouch and remove the inner Tyvek

4.

Remove Magnifuse™ Bone Graft from the Tyvek

®

pouch.

®

pouch.

PREPARATION FOR USE

Magnifuse™ Bone Graft should be hydrated prior to use to achieve optimal handling. Hydrate Magnifuse™ Bone Graft in a
small amount of fluid such as bone marrow aspirate, blood, sterile water, or sterile saline for approximately 1-2 minutes to
achieve intended consistency and handling. Simply kneading Magnifuse™ Bone Graft may enhance pliability and uniformity.
Reconstituted product must be used within the time allocated for the surgical procedure.

HANDLING AND USE

Use Magnifuse™ Bone Graft aseptically according to the surgical technique. Magnifuse™ Bone Graft is intended as a bone
graft substitute in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to stability of bony
structure.

The product should be placed in contact with well-decorticated bony surfaces of the spine (i.e. transverse processes, lamina,
facets). Use of local bone is recommended. Ensure local bone/allograft on the graft site is in direct apposition with Magnifuse™
Bone Graft. Magnifuse™ Bone Graft can be packed and shaped to contour to the surgical site. The product can be secured to
the graft site, if desired, via sutures, staples, or wires. Close the site using standard closure techniques.

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 the product. Contact Medtronic for return
information.

PACKAGING

Devices are supplied sterile. Packages for components should be intact upon receipt. Once the seal on the sterile package is
broken, do not resterilize. 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

Refer to product package label for specific storage conditions. Do not freeze. It is the responsibility of the transplant facility or
clinician to maintain tissue intended for transplantation in appropriate recommended storage conditions prior to transplant.

For European Economic Area audience only: the customer will communicate serious adverse events (meaning any untoward
occurrence associated with procurement, testing, processing, storage, and distribution of tissues and cells that might lead to
transmission of 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 (meaning an unintended response,
including communicable disease, in the donor or in the recipient associated with 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 Medtronic.

REFERENCES

Standards for Tissue Banking (current version), American Association of Tissue Banks, McLean, VA.
Current Policies and Procedures of Medtronic, Eatontown, N.J.
21CFR1271 titled “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 “Recommendations to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease By Blood and Blood products,” 4/2020.

European Directive 2004/23/EC On setting standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage, and distribution of human tissues and cells including amendments.

European Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards
certain technical requirements for the donation, procurement and testing of human tissues and cells including amendments.

COMMISSION DIRECTIVE 2012/39/EU amending Directive 2006/17/EC as regards certain technical requirements for the
testing of human tissues and cells.

European Directive 2006/86/EC implementing directive 2004/23/EC of the European Parliament and of the Council as regards
traceability requirements, notification of serious adverse reactions and events, and certain technical requirements for the coding,
processing, preservation, storage, and distribution of human tissues and cells including amendments.

European Directive 2012/39/EU amending Directive 2006/17/EC as regards certain technical requirements for the testing of
human tissues and cells.

European Directive 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the
coding of human tissues and cells.

European Directive 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the
equivalent standards of quality and safety of imported tissues and cells.

Relevant national transpositions of directives 2004/23/EC, 2006/17/EC, and 2006/86/EC.

NOTES

1

Center for Biologics Evaluation and Research, “Points to Consider in the Characterization of Cell Lines Used to Produce

Biologicals” (FDA) 1993.

2

Center for Biologics Evaluation and Research, “Points to Consider in the Manufacture and Testing of Monoclonal Antibody

Products for Human Use” (FDA) 1997.

3

Kozak RW. Viral Removal and Inactivation Issues for Biological Products. Proceedings of the 1991 Technical Program

Pharmaceutical and Cosmetic Industries Exposition and Conference. 1991: 253-260.

4

Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on

Safety Medicines, Note for Guidance: “Validation of Virus Removal and Inactivation Procedures,” Biologicals 1991; 19-247-251.

5

Committee for Proprietary Medicinal Products: EEC Council Directive 89/381: “Medicinal Products Derived from Human

Plasma” (Revised Draft 1995).

6

Committee for Proprietary Medicinal Products: 1995 Revised CPMP Guidelines. Virus Validation Studies: The design,

contribution, and interpretation of studies validating the inactivation and removal of viruses (revised).

7

ICH Viral Safety Document Final September 1998: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines

of Human or Animal Origin.

MRI INFORMATION

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

If Magnifuse™ Bone Graft 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.

RETURNS

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

PRODUCT COMPLAINTS

For product problems, contact Medtronic.
Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the

competent authority of the Member State in which they are established.

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.

To access the Summary of Safety and Clinical Performance for this device go to https://ec.europa.eu/tools/eudamed.
©2022 Medtronic Sofamor Danek USA, Inc. All rights reserved.

DISTRIBUTED BY:

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

EXPLANATION OF SYMBOLS

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

30 °C

15 °C

Temperature limit

Do not re-use

Manufacturer

Date of manufacture

Batch code

Catalogue number

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

For US audiences only

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

Sterilized using aseptic processing techniques

Do not resterilize

Use-by date

Consult instructions for use at this website.

MR Safe

Serial Number

Medical device

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.