Medtronic 7509007 Instructions for Use

Magnifuse™ Bone Graft M708348B348E Rev. F

2022-06-24

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 allograft unit is intended for single patient, single use 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 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), cleaned using 70% alcohol, washed with purified water, and sonicated. This allograft may
also have been processed with an additional surfactant. Subsequent demineralization of the 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. Tissue components were sealed in a
resorbable mesh pouch to form the final allograft product. As 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 the
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*. This 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. The lot number and/or serial
number, expiration date, product code, quantity (volume or size), and additional information are listed on the package label.

For US audiences only
Caution: Federal law (USA) restricts this product to sale by or on the order of a surgeon.
The device lifetime for demineralized bone matrix (DBM) allograft is two years in which it is expected to achieve its performance

and maintain its safety.

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 the current concepts and study design elements for process validation studies for the removal and/or inactivation of viruses in
the 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 the risk of disease transmission via the use of this allograft beyond the

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 in order 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), surfactant, and other processing solutions used in
processing bone tissue as well as the 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 the viral inactivation and extensive tissue donor selection and qualification
processes used in providing this tissue graft, transmission of infectious disease through the use of this 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, 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 diseases 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

Results of the relevant communicable 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). 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 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