Mastergraft™ Putty M708348B115E Rev. C
2021-05-25
IMPORTANT INFORMATION ON THE MASTERGRAFT™ PUTTY
Note: not all parts may be available in each geography.
PURPOSE
Mastergraft™ Putty is intended to help fill voids or gaps in bone, which may be surgically created osseous defects, or osseous
defects caused by traumatic injury to the bone. Mastergraft™ Putty provides bone void fillers that resorb and are replaced with
bone during the natural healing process.
DESCRIPTION
Mastergraft™ Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium
phosphate ceramic. The collagen component in the Mastergraft™ Putty device is Type I bovine collagen. The biphasic ceramic
portion of Mastergraft™ Putty is provided in a 15% hydroxyapatite and 85% β-tricalcium phosphate formulation. Mastergraft™
Putty is supplied as a sterile, dry, solid, construct hydrated for single patient use and is a moldable form of bone void filler.
Mastergraft™ Putty is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a
rate consistent with bone healing. Mastergraft™ Putty is biocompatible. Mastergraft™ Putty readily absorbs bone marrow
aspirate and was shown to heal bone defects.
Medtronic expressly warrants that this product is fabricated from hydroxyapatite and β-tricalcium phosphate. Implied warranties
of merchantability and fitness for a particular purpose or use are specifically excluded.
The device lifetime for Mastergraft™ is 6 months in which the device is expected to achieve its performance (e.g. provide a
resorbable scaffold to fill a skeletal defect) until bone healing occurs. After healing, the device resorbs and is replaced with bone
during the natural skeletal remodeling process. The device is further designed to maintain its safety over the life of the patient
and is not intended to be removed once bone healing has been achieved.
INDICATIONS
Mastergraft™ Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone
void filler for bony voids or gaps not intrinsic to the stability of the bony structure. Additionally, Mastergraft™ Putty can be used
with autograft as a bone graft extender. Mastergraft™ Putty is to be gently packed into bony voids or gaps of the skeletal
system (e.g. the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects
or osseous defects created from traumatic injury to the bone. Mastergraft™ Putty resorbs and is replaced with bone during the
healing process.
CONTRAINDICATIONS
This product is not intended to provide structural support during the healing process. Therefore, Mastergraft™ Putty is
contraindicated where the device is intended as structural support in the skeletal system. Contraindications include:
▪ Severe neurological or vascular disease.
▪ Uncontrolled diabetes.
▪ Hypercalcemia.
▪ Pregnancy.
▪ Where stabilization of fracture is not possible.
▪ Segmental defects without supplemental fixation.
▪ Where there is significant vascular impairment proximal to the graft site.
▪ When there are systemic and/or metabolic disorders that affect the bone or wound healing.
▪ Patients unwilling to follow postoperative instructions.
▪ Cases not described in the indications.
Mastergraft™ Putty should not be used in patients with a known history of hypersensitivity to bovine derived materials.
POTENTIAL ADVERSE EVENTS
Potential adverse events include:
▪ Deformity of the bone at the surgical site.
▪ Fracture or extrusion of Mastergraft™ Putty, with or without generation of particulate debris.
▪ Wound complications including hematoma, site damage, infection, bone fracture, and other complications common to any
surgical procedure.
▪ Incomplete, or lack of, osseous ingrowth into bone void, as possible with any bone filler.
WARNINGS AND PRECAUTIONS
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise results.
As with any surgical procedure, care should be demonstrated in treating patients with preexisting conditions that may impact
success of the surgical procedure. This includes patients with bleeding disorders of any etiology, long-term steroidal therapy,
immunosuppressive therapy, or high dosage radiation therapy.
Mastergraft™ Putty does not possess sufficient mechanical strength to support reduction of a defect site prior to soft and hard
tissue ingrowth. Rigid fixation methods are recommended as needed to ensure stabilization of the defect. Complete
postoperative wound closure is essential.
Use this device as supplied and in accordance with the handling and use information provided. The device readily absorbs
fluids. Therefore, use caution when using the device around chemicals, wound solutions, disinfectants or drugs including
antibiotics as the effects of these materials in contact with the device was not assessed.
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.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information in this document should be conveyed to the patient.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
HANDLING AND USE
Mastergraft™ Putty is provided sterile and should be considered sterile unless the inner packaging has been opened or
damaged. Unused portions contaminated with blood or human tissue should be disposed of in a properly labeled biohazard
receptacle in accordance with facility procedures.
Use Mastergraft™ Putty according to the following techniques:
A. Bone Marrow Aspirate (BMA) plus Mastergraft™ Putty
Aspirate Bone Marrow
BMA should be obtained immediately prior to implantation and should be aspirated in a 1:1 ratio of bone marrow to
Mastergraft™ Putty (e.g. 1ml of bone marrow for each 1cc of Mastergraft™ Putty).
1. Based on size/volume of defect, determine the amount of material (cc/ml) needed to completely fill the bony void.
2. Locate the posterior or anterior superior iliac crest. Using sterile technique, prepare surgical site.
3. Percutaneously introduce the aspiration needle into the iliac crest. To stabilize the needle and enhance user control, hold
the proximal end of the T-handle in palm and place the index finger against the shaft of the needle near the crown.
4. Use gentle but firm pressure to advance the needle. Rotate needle 45° in an alternating clockwise – counter clockwise
motion. Decreased resistance is experienced upon entrance into the marrow cavity. If the needle is advanced beyond
the marrow cavity, aspiration of marrow will be prevented. Should this occur, slowly withdraw the needle from the
opposing iliac crest wall while rotating the needle 45° in an alternating clockwise – counter clockwise motion until marrow
can be aspirated.
5. Remove stylet from the cannula of the needle.
6.
Attach a 10ml syringe with a Luer-lok™ or Lee-lok
7. Aspirate the desired amount of marrow by retracting the syringe plunger. To maintain the highest quality marrow, a
maximum of 3ml of marrow should be withdrawn from any one aspiration site. If more marrow is needed, move the
needle 1cm along the iliac crest and repeat steps 3 through 6 as needed. Aspiration of peripheral (venous) blood should
be avoided.
8. Once the desired volume of marrow is collected, remove the needle from the syringe.
9. Remove needle from wound and close wound using standard surgical technique.
Mastergraft™ Putty Preparation
1. Uniformly apply BMA in 1:1 ratio to Mastergraft™ Putty (e.g. 1ml of bone marrow for each 1cc of Mastergraft™ Putty).
2. Let set for a minimum of 5 minutes to allow for full hydration.
3. Mold Mastergraft™ Putty using kneading technique.
4. Implant Mastergraft™ Putty/BMA material.
B. BMA plus Autograft plus Mastergraft™ Putty
Aspirate Bone Marrow
BMA should be obtained immediately prior to implantation and should be aspirated in a 1:1 ratio of bone marrow to
Mastergraft™ Putty (e.g. 1ml of bone marrow for each 1cc of Mastergraft™ Putty).
1. Based on size/volume of defect, determine the amount of material (cc/ml) needed to completely fill the bony void.
2. Locate the posterior or anterior superior iliac crest. Using sterile technique, prepare surgical site.
3. Percutaneously introduce the aspiration needle into the iliac crest. To stabilize the needle and enhance user control, hold
the proximal end of the T-handle in palm and place the index finger against the shaft of the needle near the crown.
®
taper to the hub of the aspiration needle.
4. Use gentle but firm pressure to advance the needle. Rotate needle 45° in an alternating clockwise – counter clockwise
motion. Decreased resistance is experienced upon entrance into the marrow cavity. If the needle is advanced beyond
the marrow cavity, aspiration of marrow will be prevented. Should this occur, slowly withdraw the needle from the
opposing iliac crest wall while rotating the needle 45° in alternating clockwise – counter clockwise motion until marrow
can be aspirated.
5. Remove stylet from the cannula of the needle.
6.
Attach a 10ml syringe with a Luer-lok™ or Lee-lok
7. Aspirate the desired amount of marrow by retracting the syringe plunger. To maintain the highest quality marrow, a
maximum of 3ml of marrow should be withdrawn from any one aspiration site. If more marrow is needed, move the
needle 1cm along the iliac crest and repeat steps 3 through 6 as needed. Aspiration of peripheral (venous) blood should
be avoided.
8. Once the desired volume of marrow is collected, remove the needle from the syringe.
9. Remove needle from wound and close wound using standard surgical technique.
Mastergraft™ Putty Preparation
1. Uniformly apply BMA in 1:1 ratio to Mastergraft™ Putty (e.g. 1ml of bone marrow for each 1cc of Mastergraft™ Putty).
2. Let set for a minimum of 5 minutes to allow for full hydration. Add autograft to the Mastergraft™ Putty, with a lower limit
of 25% Mastergraft™ Putty to 75% autograft or with an upper limit 50% of Mastergraft™ Putty to 50% autograft bone.
3. Mold Mastergraft™ Putty/BMA/autograft using kneading technique.
4. Implant Mastergraft™ Putty/BMA/autograft material.
C. Sterile Water plus Mastergraft™ Putty plus Autograft
Mastergraft™ Putty Preparation
1. Uniformly apply sterile water in 1:1 ratio to Mastergraft™ Putty (e.g. 1ml of sterile water for each 1cc of Mastergraft™
Putty).
2. Let set for a minimum of 5 minutes to allow for full hydration.
3. Add autograft to the Mastergraft™ Putty, with a lower limit of 25% Mastergraft™ Putty to 75% autograft or with an upper
limit 50% of Mastergraft™ Putty to 50% autograft bone.
4. Mold Mastergraft™ Putty/sterile water/autograft mixture using kneading technique.
5. Implant Mastergraft™ Putty/sterile water/autograft material.
®
taper to the hub of the aspiration needle.
POSTOPERATIVE
When explanting and/or disposing of a device, 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.
VISUAL INSPECTION
Visually inspect all sterile-barrier packaging before use. If the sterile barrier is damaged or the integrity is compromised, do not
use the product. Contact Medtronic for return information.
Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for return
information.
PACKAGING
Devices are supplied sterile. Packages for each of the components should be intact upon receipt. Once the seal on the sterile
package is broken, the product should not be re-sterilized. 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
See package label for specific storage conditions. Do not freeze. It is the responsibility of the transplant facility or clinician to
maintain the tissue intended for transplantation in the appropriate recommended storage conditions prior to transplant.
MRI INFORMATION
MR Safe
Mastergraft™ Putty is MR Safe.
Mastergraft™ Putty 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, Mastergraft™ Putty is not susceptible to
heating due to RF (radio frequency) fields. As such, Mastergraft™ Putty can justifiably be labeled as MR-Safe per ASTM F2503.
If Mastergraft™ Putty is used in connection with any device which is not MR Conditional, be advised this combination has not
been tested in the MR environment and, therefore, higher heating and possible injury to the patient may occur.
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.
After the EUDAMED website is launched, the Summary of Safety and Clinical Performance (SSCP) can be found at https://
ec.europa.eu/tools/eudamed.
©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.
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
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
Importer
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Consult instructions for use at this website.
Do not re-use
Batch code
Manufacturer
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
17 °C
Catalogue number
For US audiences only
This device complies with applicable European Union
regulations and directives.
Sterilized using irradiation
Use-by date
Caution
Do not resterilize
Do not use if package is damaged
MR Safe
27°C
Temperature limit 17°C to 27°C
Contains biological material of animal origin
Medical device
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 sterile barrier is present.
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