Mastergraft Putty - Bone implant material, biological, animal-source

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

Class III

Manufactured by:

Medtronic Sofamor Danek USA Inc 1800 Pyramid Place, Memphis, Tennessee, 38132 United States Of America

Therapeutic area:

46425 - Bone matrix implant, animal-derived, bioabsorbable

Therapeutic indications:

MASTERGRAFT? Putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a mouldable form of bone void filler. MASTERGRAFT? products are biocompatible, osteoconductive, porous implants that allows for bony in growth across the graft site while resorbing at a rate consistent with bone healing. 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 a bone void filler that is resorbed and is replaced with bone during the natural healing process. The putty when 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 that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT Putty can be used with autograft as a bone extender. Specific indications for use include oral/maxillofacial augmentation or reconstruction.

Product summary:

Bone implant material, biological, animal-source

Authorization status:

A

Authorization date:

2013-09-26

Patient Information leaflet

M708348B115E
Rev. B
MEDTRONIC AUSTRALASIA PTY LTD
MEDTRONIC SOFAMOR DANEK USA, INC.
MEDTRONIC B.V.
97 Waterloo Rd
1800 Pyramid Place
Earl Bakkenstraat 10
North Ryde, NSW 2113
Memphis, TN 38132
6422 PJ Heerlen
Australia
Telephone
800 933 2635 (In U.S.A.)
The Netherlands
901 396 3133 (Outside U.S.A.)
Tel: + 31 45 566 80 00
Fax
901 396 0356
IMPORTANT INFORMATION ON MASTERGRAFT® PUTTY
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 percent
hydroxyapatite and 85 percent
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 a 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 has been 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.
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 that
are not intrinsic to the stability of the bony structure.
Additionally, MASTERGRAFT® Putty can be used with autograft as a bone
gra