Medtronic 7610320 Instructions for Use
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.
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