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.