Medtronic 005110 Instructions for Use

Progenix™ Putty and Progenix™

M708348B779E Rev. C

Plus

2022-04-08

IMPORTANT INFORMATION ON PROGENIX™ PUTTY AND PROGENIX™ PLUS

This package contains donated human allograft tissue intended for transplantation.

DESCRIPTION

Progenix™ products contain human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of
bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to
achieve a flowable or moldable consistency. Progenix™ is available in two forms: Putty and Plus. Progenix™ Plus contains two
different sized demineralized bone particles.

Progenix™ Putty and Progenix™ Plus are single use products intended for use in the oralmaxillofacial region. Additionally,
these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in ready-to­use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown
to be osteoinductive in an athymic rat assay, as well as osteoconductive, allowing for bony ingrowth across the graft site while
resorbing at a rate consistent with bony healing.

No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.

INDICATIONS

Progenix™ Putty and Progenix™ Plus may be used alone or in combination with autograft bone and/or autogenous bone
marrow for use as a bone graft extender, substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the
bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or
osseous defects created from traumatic injury to the bone. Progenix™ Putty and Progenix™ Plus provide a bone void filler that
is resorbed/remodeled and replaced by host bone during the healing process.

Progenix™ Putty and Progenix™ Plus are intended to be used alone or in combination with autogenous bone and/or bone
marrow aspirate for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of cranial oral
maxiollofacial and dental intraosseous defects including:

▪ Ridge augmentation.
▪ Filling of cystic defect.
▪ Filling of extraction sites.
▪ Filling of lesions of periodontal origin.
▪ Craniofacial augmentation.
▪ Filling of defects of endodontic origin.
▪ Mandibular reconstruction.
▪ Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture.
▪ Filling of resection defects in benign bone tumors, benign cysts, or other osseous defects in the alveolar ridge wall.

Note: the user should consider the fact that Progenix™ Plus contains demineralized bone chips approximately 2-4mm in
determining the appropriateness of this allograft for use in small defects.

CONTRAINDICATIONS

These products are contraindicated, and should not be used, in patients who have known allergies to bovine collagen, sodium
alginate or polymyxin and/or bacitracin antibiotics.

These products do not possess sufficient mechanical strength to support the reduction of a defect site prior to soft and hard
tissue ingrowth. These products are contraindicated where stabilization of the defect is not possible.

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 the
transplantation of an allograft. Any adverse outcomes potentially attributable to Progenix™ must be promptly reported to
Medtronic at [phone] or [phone].

WARNINGS AND PRECAUTIONS

A small number of patients may experience localized immunological reactions resulting from the use of this device (e.g.
transient localized edema and swelling, and rash). The safety and effectiveness of the device in these patients has not been
established.

Over-pressurizing the device may result in extrusion beyond the site of its intended application and may damage the
surrounding tissues.

Over-pressurizing the defect site may lead to fat embolization or embolization of the device’s material into the bloodstream.

For US Audiences Only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician or dentist.
Physician and dentist note: although physicians and dentists are the learned intermediary between the company and the

patient, the important medical information given in this document should be conveyed to the patient.

DONOR SCREENING AND TESTING

The tissue donor, from whom this allograft was derived, was screened for high risk factors, clinical signs, and symptoms of HIV,
hepatitis, CJD/vCJD and other diseases and medical conditions that would contraindicate the donation of tissues in accordance
with current FDA regulations and guidance documents, state regulations, standards established by the American Association of
Tissue Banks, and current US Public Health Services recommendations.

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

The results of all the relevant communicable disease tests referenced above were found to be negative or non-reactive.
In addition to the tests listed above, other tests may have been performed including tests for HBV NAT (Hepatitis B virus nucleic

acid amplification testing) and WNV NAT (West Nile Virus nucleic acid amplification testing). If HBV NAT and WNV NAT tests
were performed, the results of these tests were negative or non-reactive, and the results of any other tests performed were
negative or otherwise acceptable for eligibility of donors of musculoskeletal tissues.

The 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 by a
Medical Director of Community Tissue Services, Dayton, OH, 45402. Based on this evaluation, the donor was determined to
meet donor eligibility criteria current at the time of recovery. The 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”.

The 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 the eligibility of this human tissue are on file at Medtronic and are available upon request.

The final, processed tissue allograft was released for transplantation based on the initial donor eligibility determination and on a
post-processing review and determination that the allograft met all processing requirements and allograft specifications.

Documentation specifying details of donor screening, infectious disease testing results, and testing facilities for a particular
tissue donor will be made available when requested by the implanting physician only.

VIRAL INACTIVATION

Progenix™ devices are produced from tissue and collagen which undergoes processing steps validated to inactivate a panel of
viruses representative of those which are clinically relevant. The cortical bone used to produce the DBM undergoes a
proprietary process demonstrated to inactivate viruses. Furthermore, the DBM undergoes additional steps which are also
effective at inactivating viruses. The viral inactivation testing demonstrates suitable viral inactivation potential of the processing
methods for a wide range of potential human viruses. These processing steps further reduce the risk of viral contamination
beyond donor screening and testing.

RECOVERY

This allograft was prepared from human bone tissue recovered in the US from a deceased donor using aseptic surgical
techniques and microbiologically-tested during recovery.

TISSUE PROCESSING

This product is processed into its final form in a controlled environment. Traces of some or all of the following reagents used
during processing may remain on the graft:

▪ Hydrochloric acid.
▪ Sodium phosphate buffer.
▪ Isopropyl alcohol.
▪ Hydrogen peroxide.
▪ Detergents (nonoxynol 9, nonidet P40, Bri 35).
▪ Polymyxin.
▪ Bacitracin.

Note: no ß-lactam antibiotics are used during processing of the Progenix™ devices.

Grafts are terminally sterilized via e-beam irradiation using a validated process that meets or exceeds requirements for product
sterilization (i.e. a SAL of 10

-6

per ISO 11137-2).

OSTEOINDUCTIVITY POTENTIAL

Every lot of Progenix™ Putty and Progenix™ Plus final product must induce bone formation when evaluated in a validated
assay prior to being released for use. Every lot must show histologic evidence of osteoinduction through the presence of
osteoblasts, chondroblasts, and/or woven bone. Osteoinduction assay results using the athymic rat assay should not be
interpreted to predict clinical performances in human subjects.

DISTRIBUTION

Allografts are shipped via overnight services unless an alternative carrier or method is requested.

RECEIPT INSPECTION

Upon arrival, unpack and inspect the graft. Verify you received the correct graft type and the expiration date has not elapsed.
Should you receive the incorrect order or find that the shipping container and graft packaging integrity is compromised,
immediately call [phone] or [phone].

PACKAGING

The Progenix™ devices packaging should be intact upon receipt. Damaged packages or products should not be used, and
should be returned to SGT.

STORAGE

Products must be stored at ambient conditions. It is the responsibility of the end user to maintain grafts intended for
transplantation at appropriate storage conditions. Storage conditions should be documented.

ALLOGRAFT TISSUE TRACING RECORD

Federal (USA) regulations under 21 CFR 1271 establish requirements for tracking of human tissue products. 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 and is recorded in Medtronic’s distribution records to track the tissue to the consignee or user/tissue
transplant facility. It is the end-user’s responsibility to maintain recipient records for the purpose of tissue tracking. This lot or
serial number should be recorded in the user/tissue transplant facility’s records and in the tissue recipient's medical record.
Additional tissue identification labels are provided in each tissue graft package for your convenience in maintaining records.
Also, each tissue unit has an Allograft Tissue Tracing Record included. Remove a tissue identification label from the graft
package and affix it to the designated area on the Allograft Tissue Tracing Record. Complete the Allograft Tissue Tracing
Record and return it promptly to SGT.

ALLOGRAFT PREPARATION

▪ Once opened, this allograft product must be used for the current procedure or discarded.
▪ This allograft product may not be re-sterilized.
▪ Adhere to instructions provided on surgical techniques and use of instrumentation.
▪ Additional allografts of varying types and sizes should be accessible in case of an unexpected need.
▪ The box acts to protect the allograft during shipping and storage.

DIRECTIONS FOR USE IN ORALMAXILLOFACIAL REGION

Progenix™ Putty and Progenix™ Plus are ready-to-use in the packaging provided.

1. Remove packaged tray, product information sheet, and Allograft Tissue Tracing Record from the box.

2. Affix Peel-off Labels with tissue identification number to patient records and the Allograft Tissue Tracing Record. Fill out

information and return. Tissue utilization reports are necessary for the purpose of tracing tissue/recipient information in the
unlikely event of suspected or actual transmission of disease and allow for appropriate actions.

3. Using sterile technique, open the outer tray and introduce the inner tray and its contents to the sterile field. Discard outer
tray.

4. In sterile field, remove syringe from inner tray. Discard tray packaging. Product is contained in a sterile syringe and may be
mixed according to the surgeon’s preference. Remove and discard syringe cap prior to use.

5. Proper preparation of the graft site is important for graft incorporation and bone formation.

6. For use in the oralmaxillofacial region, the graft may be used alone, or in combination with autogenous bone and/or bone

marrow aspirate.

MRI INFORMATION

MR Safe
Progenix™ Putty and Progenix™ Plus are MR Safe.
Progenix™ Putty and Progenix™ Plus are nonconducting or nonmagnetic items which pose no known hazards in all MR

environments for magnetically induced displacement force and magnetically induced torque. In addition, Progenix™ Putty and
Progenix™ Plus are not susceptible to heating due to RF (radio frequency) fields. As such, Progenix™ Putty and Progenix™
Plus can justifiably be labeled as MR-Safe per ASTM F2503.

FREQUENTLY ASKED QUESTIONS

Q. If we don’t use all of the putty in a syringe at once, can we use it later in the same case?

A. Yes. Place the cap on the syringe until the product is needed.

Q. Can unused portions of Progenix™ products be reused in another surgery?

A. No. Individual packages are for use in one patient, on a single occasion only.

PRODUCT COMPLAINTS

To report any product problems, contact Medtronic.

FURTHER INFORMATION

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

©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

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

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

Sterilized using irradiation

Do not re-use

Manufacturer

Date of manufacture

Use-by date

Batch code

Catalogue number

For US audiences only

MR Safe

Consult instructions for use