Magnifuse™ II Bone Graft M708348B334E Rev. F
2022-06-24
IMPORTANT INFORMATION ON MAGNIFUSE™ ll 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™ ll Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft
tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with
supplied injection molded spatula, funnel, and plunger. This product enables clinicians to generate a construct having a
particular physical form and handling property. No additional carrier is added to the allograft material.
Magnifuse™ ll Bone Graft was prepared from human bone tissue recovered from a cadaveric donor using aseptic surgical
techniques and was microbiologically tested during recovery. The tissue was further processed under aseptic conditions and
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. 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™ ll 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™ II 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 per 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). Bone forming activity exhibited by Magnifuse™ II Bone Graft
in this athymic rat surrogate assay should not be interpreted as a predictor of clinical performance.
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 these devices to sale by or on the order of a surgeon.
The device lifetime for Magnifuse™ ll Bone Graft is two years in which it is expected to achieve its performance and maintain its
safety.
VIRAL INACTIVATION PROCEDURES
Magnifuse™ ll 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
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
. Studies were performed in certified conformity with Good
INDICATIONS
Magnifuse™ II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e.
posterolateral spine and pelvis) not intrinsic to stability of bony structure. Voids or gaps may be surgically created defects or
defects created by traumatic injury to bone. Magnifuse™ II 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 viral inactivation and extensive tissue donor selection and qualification
processes used in providing this tissue graft, transmission of infectious disease through use of this tissue graft is still possible.
Bacterial infection at the graft site may also occur. Adverse outcomes potentially attributable to Magnifuse™ II 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 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 & 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 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 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, 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”, 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
AlloSource
Centennial, CO 80111
Names and addresses of the testing laboratories, the listing and interpretation of required communicable disease tests, a listing
of 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 are available upon request.
Final tissue allograft product was released by Medtronic based on initial donor eligibility determination and on a post-processing
review and determination that the product met all processing requirements and specifications.
This tissue allograft was released for transplantation.
STERILITY
Magnifuse™ ll Bone Graft was aseptically processed and tested for sterility according to procedures in the current 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. Package labels
containing “Pretreated with Gamma Irradiation” indicate low dose (1.0–1.8 Mrad) gamma irradiation was used as a means of
reducing the 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 tissue 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.
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 for
appropriate actions.
Note: once a package seal is broken, the tissue should 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.
GRAFT SIZE
Magnifuse™ II Bone Graft is available in two sizes: medium and large. The following table indicates the approximate size of
Magnifuse™ II Bone Graft made following the graft preparation instructions.
Magnifuse™ II Size Length Width Thickness
Medium 5cm 2.5cm 1.5cm
Large 10cm 2.5cm 1.5cm
PREPARATION FOR USE
1. Open outer packaging and transfer inner packaging to sterile field.
2. Using a syringe, inject sterile water, sterile saline, or blood into the pouch containing allograft material. Knead allograft
packaging to ensure complete hydration.
Magnifuse™ II Size Hydration volume
Medium 5cc to hydrate allograft in pouch
Large 10cc to hydrate allograft in pouch
3. Open allograft package and transfer contents to a sterile bowl. Mix with morselized autograft to obtain a 1:1 ratio with
homogeneous allograft/autograft mixture.
Note: autograft size should be less than 2mm in diameter to help prevent clogging when inserting into funnel/mesh.
4. Remove funnel and mesh from inner packaging.
5. Place PGA mesh pouch on the tip of funnel barrel and advance toward barrel and funnel junction.
6. Transfer half of allograft/autograft mixture to funnel and advance material into barrel with provided spatula.
7. Insert plunger and compress allograft/autograft mixture within barrel. If voids are noticed in graft mass, compress harder
with plunger.
Note: verify the desired length of bone graft was achieved by comparing the length of the graft mass with the surgical gap
you plan to bridge with the device.
8. Press plunger into barrel and express graft mass into PGA mesh pouch.
9. Once the pouch with the graft material is removed from the barrel, tighten the closure tie to prevent graft material from
loosening.
10. Cut remaining mesh pouch with sterile surgical scissors.
11. Repeat steps 5 through 10 to create second graft.
Reconstituted product must be used within the time allocated for the surgical procedure.
HANDLING AND USE
Magnifuse™ II Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ II Bone
Graft may be mixed with blood, sterile saline, or sterile water to adjust consistency and handling. Use Magnifuse™ II Bone Graft
aseptically according to the surgical technique.
Recommended usage: once the graft site is properly prepared, Magnifuse™ II Bone Graft should be placed in the welldecorticated graft site. The product can be secured via sutures, staples, or wires if needed.
Recommended posterolateral spine usage: Magnifuse™ II Bone Graft is comprised of human bone allograft tissue matrix mixed
1:1 with autograft tissue in a resorbable mesh pouch. The product should be placed between two well-decorticated transverse
processes. Ensure the prepared graft site is in direct contact with graft material. Magnifuse™ II Bone Graft can be packed and
shaped to contour to the surgical site. The product can be secured to the graft site, if necessary, 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 re-sterilize. 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 the 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.
MRI INFORMATION
MR Safe
Magnifuse™ ll Bone Graft is MR Safe.
Magnifuse™ II 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™ II Bone Graft is not
susceptible to heating due to RF (radio frequency) fields. As such, Magnifuse™ II Bone Graft can justifiably be labeled as MR
Safe per ASTM F2503.
If Magnifuse™ II 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.
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.
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.
©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
Catalogue number
Batch code
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
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.
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