Surgitime Titanium (Titanium Mesh)
SURGITIME TITANIUM MESH 34 X 25 MM (0.04 MM / 0.15 MM)SURGITIME TITANIUM MESH 34 X 25 MM (0.04 MM / 0.85 MM)
SURGITIME TITANIUM MESH 34 X 25 MM (0.08 MM / 0.85 MM)
SURGITIME TITANIUM MESH 60 X 60 MM (0.08 MM / 0.85 MM)
Titanium (Titanium Mesh) - CE 0434
DESCRIPTION AND ACTION FOUNDATIONS
Titanium (Titanium Mesh) is a no absorbable titanium screen made of pure
Titanium (ASTM F-67), that helps in bone neoformation, acting as barrier that
block the migration of epithelial and connective tissue, avoiding competition
with bone graft. They come in many different lengths, widths, thicknesses, and
titanium mesh provides excellent biocompatibility, and occlusive property, and
it’s permeable allowing the transmission of nutrients, and it’s easy to use,
since it’s very malleable and can be cut for surgical site adaptations, having
the capacity to keep the regenerative space intact with the possibility of bone
graft vascularization on both sides (periosteum and endosseous). It has been
designed to ensure a tridimensional reconstruction of alveolar bone defects and
to facilitate bone replacement through the replacement material’s adequate
it has memory, it can be premolded into the defect and fixed with graft bolts
and Bionnovation fixation on the bone surface, however it is not necessary to
use a bone graft screw for the titanium mesh to exercise its function, and its
use varies according to the responsible professional’s options.
titanium mesh conforms the tissue contours and also is rigid enough to keep a
space on the bone defect and the overlapping tissue. It’s important to use
Surgitime Titanium (titanium mesh) temporarily in order to promote an adequate
environment, allowing the organism to utilize its natural cicatrization
potential and regenerate the lost or missing tissue.
The necessary stay
for starting the osteoconduction is at least 21 days.
INDICATION AND PURPOSE OF USE
Titanium (titanium mesh) is indicated for medical regenerative procedures (orthopedics
and neurosurgery) and odonthological (periodontics, oral and maxillofacial,
implantodontics), especially for bone reconstructions. In odonthological cases
we recommend a second surgery for their removal, and since they are made of
pure titanium, there may be osseointegration when used with autogenic bone
graft, thus hindering their withdrawal. The titanium mesh’s withdrawal varies
according to the responsible professional’s options.
titanium meshes, also known as mechanical barriers for GBR – Guided Bone
Regeneration, help in bone neoformation, acting as biological barriers to avoid
cell migration from the epithelium, the conjunctive tissue and/or bacteria that
might cause bone growth inhibition, promoting an adequate space for the
formation of a natural fibrin understructure, precursor of the bone tissue. It
is an easily manipulated membrane which function is to protect the clot from
the invasion of the nonosteogenic structures and direct it, preventing its
distortion by the pressure from adjoining tissues. Surgitime titanium is anyway
a barrier even with the larger holes as mentioned in the report.
Titanium is an excellent medium for maintaining the desired crest dimensions.
Once exposed, Surgitime Titanium (Titanium mesh) prevents a great loss of graft
because an epithelial closure around the screen ends up occurring.
It is supplied
sterile, as long as kept under the ideal storage and conservation conditions
and the packing integrity has not been compromised. It is sterilized by Gamma
Radiation, and should not be used in case its validity time has expired.
PRECAUTIONS, RESTRICTIONS AND WARNINGS
The product is sterile as long as package integrity, validity term and storage
conditions are observed.
use only is the responsibility of the dentist or doctor their prior training to
use this product. Only qualified professionals with expertise in surgical
techniques and procedures necessary for proper use of the product should make
use of Surgitime Titanium. The use of incorrect surgical techniques may cause
discomfort as painful sensation, hypoesthesia, edema.
NOT RESTERILIZE AND REPROCESS IT – if it is resterilized or reprocessed its
physical-chemical properties may be altered, leading to foreign body reaction.
Resterilization especially in autoclave alters the product’s quality, and the
titanium alloy’s quality may be altered.
NOT REUTILIZE IT – even if has no damage, the mesh is exposed to loads when
implanted, becoming fragile. If it’s reutilized or utilized with an expired
validity date, it may lead to irritation, infection, inflammation and other
adverse events, thus compromising the patient’s health and safety. Bionnovation
does not recommend its reutilization, reprocessing, or resterilization, so
discard the product according to the applicable legislation for hospital waste.
titanium must be in its flat form for its correct utilization, since the mesh
has memory, and once it has been utilized it will never resume its original
format, thus compromising its functionality.
it has been installed with grafting screw and fixation, if it is reutilized
there will be alteration in holes’ diameter, thus compromising its
use of the product under inadequate surgical techniques and biosafety
conditions may harm the patient leading to unsatisfactory results.
STERILIZE THE INSTRUMENTS BEFORE USING THEM.
clinical and radiographic evaluation must be done prior to surgery, to help the
correct treatment planning. Determination of bone quality and quantity, repairs
and anatomical structures and analysis of neighbouring teeth.
Titanium (Titanium mesh) is supplied sterile – so, observe the appropriate
asepsis and antisepsis techniques.
of alcohol, tobacco, drugs and corticosteroids or inappropriate oral hygiene
may significantly compromise the success of treatment.
should be informed in advance on all potential adverse effects such as
dehiscence, inflammation, hemorrhage, allergic reaction. An incorrect surgical
technique may lead to discomfort, such as a painful sensation, hypoesthesia and
is provided on the sterile condition and once opened should be used on aseptic
conditions. One should always work with sterile fields, instruments appropriate
for the procedure and in good upkeep condition, in such a way to eliminate
infection sources and damages caused to the components by an inappropriate
Titanium (Titanium mesh) should be used only for the purpose for which it is
membrane exposure may occur in dental procedures, when no perfect adaptation to
the receiving bed or the covering tissues occurs.
odonthological cases we recommend a second surgery for its removal, and since
the product is made of pure Titanium, there may be osseointegration when used
with autogenic bone graft, hindering its withdrawal. The titanium mesh’s
withdrawal varies according to the responsible professional’s options.
occur complications impossible to be controlled, tissue inflammation or evidence
of infection is recommended the immediate removal of the material.
Titanium (Titanium mesh) is provided in sterile double packaging (25 kGy gamma
radiation). Provided the packaging’s integrity has not been somewhat
compromised, it will keep the product sterile for up to 4 years to be counted
as of the sterilization date.
are no restrictions as to maximum amount of product that can be deployed. The
amount will be determined by the professional after analyzing the size of the
Titanium must be molded according to the bone’s anatomy, and it must not be
folded in sharp angles, scored or deformed. Once it has been utilized and
molded, it must not be molded again, since it might lead to product function
correct handling of Surgitime Titanium is highly important, and it may only be
handled when deemed necessary, and excessive mesh modifications or molding may
lead to breakage and/or deformation.
surgeon shall evaluate its indication to patients diagnosed with diseases or
that use a medication that might change the reparation metabolism.
remaining material on the bottle may not be reused, resterilized or
reprocessed. Dispose of it in a de-characterized way, according to the current
legislation for hospital waste.
cases of adverse effects occurring in patients, the responsible must contact
immediately with the SAC Bionnovation (Customer Service) by the number 0800 707
3824 or by e-mail firstname.lastname@example.org. The
Bionnovation Biomedical Products is responsible for notifying the ANVISA
(Health Suveillance Agency) about the relevant occurrences according to
internal technovigilance procedure.
Titanium (Titanium mesh) was developed in order to prevent that its use does
not compromise the clinical condition of patients as well as their safety.
Note: Bionnovation suggests that the
product’s 5 identification adhesive labels with numbers are attached to patient
documentation (patient’s clinical dossier, report given to the patient, sale
invoice of the product, supplier control and sugeon control). This assures full
product traceability through the ID code and batch printed in the labels, and
prompt location of all production documents; then the product can be retained
for evaluation and analysis purposes when needed.
Titanium (Titanium mesh), like all the other membranes, should not be placed on
existing active infection or in case of any other degenerative disease that can
affect mesh implant.
must not be utilized in patients that are not able, under the clinical point of
view, to be submitted to a medical or odonthological intervention. Such as, for
example, in patients with uncompensated diabetes.
contraindicated for procedures different from those recommended in item "Use
not expose the titanium mesh to the environment, in dental procedures.
(titanium mesh) must not be utilized for bone mobilization, as an
osteosynthesis auxiliary, and to gather the bone fragments of a fracture.
SPECIAL CONDITIONS FOR THE PRODUCT’S STORAGE,
TRANSPORTATION, CONSERVATION AND/OR HANDLING
store the product away from direct sunlight, and from heat (maximum
temperature: 40°C and humidity (35% to 65%). Keep the packaging
sealed until its utilization time. Please, verify the integrity of the same
before using it. Do not use it if the sterile package has been opened, or if
it’s damaged, or if the sterilization validity date has expired in order to
avoid possible contamination. Discard any mischaracterized product according to
the applicable legislation for hospital waste, or return the damaged packages
to the factory, including the device.
Any alteration that
occurs on the surface or shape of the mesh this might have mischaracterized,
please discard it according to the applicable legislation for hospital waste,
or return the damaged packages to the factory, including the device.
the package contents on a sterile surgical field.
the flap so that later the mesh exceeds at least 2 mm the area to be protected.
the aseptic surgery techniques applicable in the case, prepare the receiving
bed for the mesh.
necessary, cut the mesh with the help of sterile scissors in the adequate size,
aiming at maximum adaptation to the work area.
the mesh to the field, leaving it flat, and thoroughly observing its edges. It
must be completely under the soft tissue and without any fold.
the flap over the mesh.
without involving the mesh. Only in cases of use for medical field, the meshes
can be involved.
surgical cement is facultative to the surgeon in charge.
painkillers or anti-inflammatory drugs may be used after surgery.
10. The titanium mesh can
be removed once its purpose is accomplished.