MASTERGRAFT
®
M708348B371 Rev. B
M708348B371E Rev. B
Matrix EXT
IMPORTANT INFORMATION ON MASTERGRAFT®MATRIX EXT
2014-10-30
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone 800 933 2635 (In U.S.A.)
901 396 3133 (Outside U.S.A.)
Fax 901 396 0356
M
ENGLISH
IMPORTANT INFORMATION ON THE MASTERGRAFT® MATRIX EXT
DESCRIPTION
MASTERGRAFT® Matrix EXT is made from a combination of medical grade puried collagen
of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is
a highly puried (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic
portion of the device is provided in a 15 percent hydroxyapatite and 85 percent β-tricalcium
phosphate formulation.
MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Matrix EXT is a biocompatible, osteoconductive, porous implant that allows
for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing.
The device readily absorbs bone marrow aspirate.
Medtronic expressly warrants that this product is fabricated from hydroxyapatite and
β-tricalcium phosphate. Implied warranties of merchantability and tness for a particular
purpose or use are specically excluded.
INDICATIONS
MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated
for bony voids or gaps not intrinsic to the stability of the bony structure and can be used
as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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. The device
resorbs and is replaced with bone during the healing process.
Matrix EXT
IMPORTANT INFORMATION ON MASTERGRAFT®MATRIX EXT
Medtronic Sofamor Danek USA, Inc.
M
1800 Pyramid Place
Memphis, TN 38132
Telephone 800 933 2635 (In U.S.A.)
901 396 3133 (Outside U.S.A.)
Fax 901 396 0356
IMPORTANT INFORMATION ON THE MASTERGRAFT® MATRIX EXT
DESCRIPTION
MASTERGRAFT® Matrix EXT is made from a combination of medical grade puried collagen
of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is
a highly puried (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic
portion of the device is provided in a 15 percent hydroxyapatite and 85 percent β-tricalcium
phosphate formulation.
MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Matrix EXT is a biocompatible, osteoconductive, porous implant that allows
for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing.
The device readily absorbs bone marrow aspirate.
Medtronic expressly warrants that this product is fabricated from hydroxyapatite and
β-tricalcium phosphate. Implied warranties of merchantability and tness for a particular
purpose or use are specically excluded.
INDICATIONS
MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated
for bony voids or gaps not intrinsic to the stability of the bony structure and can be used
as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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. The device
resorbs and is replaced with bone during the healing process.
• Hypercalcemia.
ENGLISH
2014-10-30
• Pregnancy.
CONTRAINDICATIONS
This product is not intended to provide structural support during the healing process.
Therefore, MASTERGRAFT® Matrix EXT is contraindicated where the device is intended as
structural support in the skeletal system. Conditions representing relative contraindications
include:
• Severe neurological or vascular disease.
• Uncontrolled diabetes.
• Where stabilization of fracture is not possible.
• Segmental defects without supplemental xation.
• Where there is signicant vascular impairment proximal to the graft site.
• When there are systemic and/or metabolic disorders that aect the bone or wound healing.
• Any patient unwilling to follow postoperative instructions.
• Any case not described in the indications.
• Should not be used in patients with a known history of hypersensitivity to bovine derived
materials.
POTENTIAL ADVERSE EVENTS
A listing of potential adverse events includes, but is not limited to:
• Deformity of the bone at the surgical site.
• Fracture or extrusion of MASTERGRAFT® Matrix EXT 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 in-growth into bone void, as possible with any bone ller.
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 the results.
As with any surgical procedure, care should be demonstrated in treating patients with
preexisting conditions that may impact the 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® Matrix EXT does not possess sucient mechanical strength to support
reduction of a defect site prior to soft and hard tissue ingrowth. Rigid xation 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.
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize
this product. Reuse, reprocessing, or resterilization 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.
• Where stabilization of fracture is not possible.
• Segmental defects without supplemental xation.
• Where there is signicant vascular impairment proximal to the graft site.
• When there are systemic and/or metabolic disorders that aect the bone or wound healing.
• Any patient unwilling to follow postoperative instructions.
• Any case not described in the indications.
• Should not be used in patients with a known history of hypersensitivity to bovine derived
materials.
POTENTIAL ADVERSE EVENTS
A listing of potential adverse events includes, but is not limited to:
• Deformity of the bone at the surgical site.
• Fracture or extrusion of MASTERGRAFT® Matrix EXT 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 in-growth into bone void, as possible with any bone ller.
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 the results.
As with any surgical procedure, care should be demonstrated in treating patients with
preexisting conditions that may impact the 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® Matrix EXT does not possess sucient mechanical strength to support
reduction of a defect site prior to soft and hard tissue ingrowth. Rigid xation 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.
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize
this product. Reuse, reprocessing, or resterilization 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.
CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a
Consult instructions for use
Do not re-use
Batch code
Manufacturer
Catalogue number
For US audiences only
device is for single patient use and should never be reused. Any unused portioned of the
REF
R
Warning: Never use this device if the packaging is compromised.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company
and the patient, the important medical information given in this document should be
conveyed to the patient.
!USA
FOR US AUDIENCES ONLY
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE
ORDER OF A PHYSICIAN.
HANDLING AND USE
MASTERGRAFT® Matrix EXT is provided sterile and should be considered sterile unless the
inner packaging has been opened or damaged. This product is never to be resterilized. This
product that has been contaminated with blood or human tissue should be disposed of in
a properly labeled biohazard receptacle in accordance with facility procedures.
MASTERGRAFT® MATRIX EXT
Use MASTERGRAFT® Matrix EXT according to the following techniques:
• Implant MASTERGRAFT® Matrix EXT preferably in contact with spongy autologous bone.
• Freshen the bone wall in contact with MASTERGRAFT® Matrix EXT.
• Saturate MASTERGRAFT® Matrix EXT with marrow from the patient (it is mandatory that
MASTERGRAFT® Matrix EXT be mixed with bone marrow aspirate). Bone marrow should
be obtained immediately prior to implantation and should be aspirated in a minimum
1:1 ratio of marrow to material (ex. 5ml of bone marrow for each 5cc of material).
• Once bone marrow aspirate is applied to MASTERGRAFT® Matrix EXT, allow the scaold
structure to soak for 1-3 minutes prior to implantation. Adequate soaking has occurred
once bone marrow aspirate coats all surfaces.
• Gently pack the site, but avoid overlling the bone void or compressing the treatment
site.
• Remove excess material from the treatment site.
• Close the site using standard closure techniques and discard any unused MASTERGRAFT®
Matrix EXT.
PACKAGING
MASTERGRAFT® Matrix EXT should be intact upon receipt. Damaged packages or products
should not be used, and should be returned to Medtronic.
PRODUCT COMPLAINTS
Any health care professional (e.g., customer or user of this system of products) who has
any complaints or who has experienced any dissatisfaction in the product quality, identity,
durability, reliability, safety, eectiveness, and/or performance, should notify the distributor
or Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions”
(i.e., does not meet any of its performance specications or otherwise does not perform as
intended), or is suspected of doing so, the distributor should be notied immediately. If any
CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a
Consult instructions for use
Do not re-use
Batch code
Manufacturer
Catalogue number
For US audiences only
Sterilized using irradiation
Use-by date
device is for single patient use and should never be reused. Any unused portioned of the
product that has been contaminated with blood or human tissue should be disposed of in
a properly labeled biohazard receptacle in accordance with facility procedures.
MASTERGRAFT® MATRIX EXT
Use MASTERGRAFT® Matrix EXT according to the following techniques:
• Implant MASTERGRAFT® Matrix EXT preferably in contact with spongy autologous bone.
• Freshen the bone wall in contact with MASTERGRAFT® Matrix EXT.
• Saturate MASTERGRAFT® Matrix EXT with marrow from the patient (it is mandatory that
MASTERGRAFT® Matrix EXT be mixed with bone marrow aspirate). Bone marrow should
be obtained immediately prior to implantation and should be aspirated in a minimum
1:1 ratio of marrow to material (ex. 5ml of bone marrow for each 5cc of material).
• Once bone marrow aspirate is applied to MASTERGRAFT® Matrix EXT, allow the scaold
structure to soak for 1-3 minutes prior to implantation. Adequate soaking has occurred
once bone marrow aspirate coats all surfaces.
• Gently pack the site, but avoid overlling the bone void or compressing the treatment
site.
• Remove excess material from the treatment site.
• Close the site using standard closure techniques and discard any unused MASTERGRAFT®
Matrix EXT.
PACKAGING
MASTERGRAFT® Matrix EXT should be intact upon receipt. Damaged packages or products
should not be used, and should be returned to Medtronic.
PRODUCT COMPLAINTS
Any health care professional (e.g., customer or user of this system of products) who has
any complaints or who has experienced any dissatisfaction in the product quality, identity,
durability, reliability, safety, eectiveness, and/or performance, should notify the distributor
or Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions”
(i.e., does not meet any of its performance specications or otherwise does not perform as
intended), or is suspected of doing so, the distributor should be notied immediately. If any
Medtronic product ever malfunctions and may have caused or contributed to the death or
serious injury of a patient, the distributor should be notied immediately by telephone, fax,
or written correspondence. When ling a complaint, provide the component(s) name and
REF
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STERILE R
number, lot number(s), your name and address, the nature of the complaint, and notication
of whether or not a written report from the distributor is requested.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available
at no charge upon request. If further information is needed or required, contact Medtronic.
©2014 Medtronic Sofamor Danek USA, Inc. All rights reserved.
EXPLANATION OF SYMBOLS
REF
CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a
R
Consult instructions for use
physician.
Do not re-use
Batch code
Manufacturer
Catalogue number
For US audiences only
2
LOT
!USA
STERILE R
Sterilized using irradiation
Use-by date
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