– CE 0434
Hydroxyapatite, Ca10(PO4)6(OH)2 is a hydrated
calcium phosphate, a majority component (about 95%) of the mineral phase of
human bones and teeth. It is used by the body to compound the skeleton, due to
its capacity to act as a reserve of calcium and phosphorus. Owing to its chemical
similarity with the mineral phase of bone tissues it becomes one of the most
biocompatible materials ever known, favoring the bone growth where it is
located (osteoconductive), setting up chemical bonds between it and the bone
tissue (bioactive), allowing the proliferation of fibroblasts, osteoblasts and
other bone cells, which do not differentiate from the bone surface indicating
the high surface chemical similarity.
The hydroxyapatite allows integration of bipolar
type alloys, causing water molecules and also proteins and collagen to be
absorbed at the surface thus inducing tissue regeneration.
The application of
Hydroxyapatite allows the bone tissue restoration through the osteoinduction
PURPOSE OF USE
biomaterials have been largely used as bone replacement. Hydroxyapatite is a
bone graft material successfully used in orthopedic, cranio-maxillofacial and
odontologic surgeries. It is recommended to repair defects of the base of the
skull, spinal fusion, and for orthopedicuse, it is also used for bone grafts
around dental implants and hip metallic prostheses.
STERILE - as long as maintained the integrity of the
packaging, period of validity and storage conditions.
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 Hydroxyapatite. The use of incorrect surgical techniques may cause
discomfort as painful sensation, hypoesthesia, edema. The size of the particles
should not be changed.
RESTERILIZE AND REPROCESS – If resterilized or reprocessed may occur change at
the physical chemical properties and crystallinity levels of Hydroxyapatite
causing foreign body reaction.
– If reused or used with expired validity, may cause irritation, inflammation
and other adverse events, compromising the health and safety of the patient.
The use of the
product with surgical techniques and inadequate biosecurity conditions may
damage the patient leading to unsatisfactory results.
the tools before using them.
The 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.
In all surgeries
involving Hydroxyapatite particles must be observed proper techniques used for
asepsis and antisepsis.
The abuse of
alcohol, tobacco, drugs, steroids or lack of proper oral hygiene can
significantly impair the success of the treatment.
adverse effects as dehiscence, inflammation, bone loss, hemorrhage, must be
previously informed to the patient.
It is supplied
in sterile condition and once opened should be used in aseptic conditions.
Should always work with sterile fields, appropriate instruments to the
procedure and in good condition in order to eliminate sources of infection and
damage to the product.
should be used only for the purpose for which it is intended.
complications impossible to be controlled, tissue inflammation or evidence of
infection is recommended the immediate removal of the material.
is provided in sterile double packaging (25 KGy gamma radiation). Provided that
the package integrity is not compromised in any way, it will save the sterile
product up to 3 years from the date of sterilization.
There 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 surgical
should evaluate the indication in patients who are carriers of diseases or are
making use of medication that may alter the repair metabolism.
The remainder of
the packaging material should not be reused, reprocessed or resterilized,
discard it mischaracterized as current legislation for medical waste, do not
discard contaminated products in household waste.
In 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 Surveillance Agency) about the
relevant occurrences according to internal technovigilance procedure.
was developed in order to prevent that its use does not compromise the clinical
condition of patients as well as their safety.
we recommend that the identification stickers that come with the product be
attached to the patient’s documentation: clinical record of the patient, the
report delivered to the patient, product sales invoice, vendor control and
control of the surgeon in charge, ensuring the complete traceability of the
as well as all the other biomaterials, should not be placed on an existing
active infection or in any other degenerative disease that might affect the
It must not be
utilized in patients that are notable, under the clinical point of view, to be
submitted to a medical or odonthological intervention. Such as, for example, in
patients with uncompensated diabetes.
is not indicated for odontopediatric patients.
contraindicated for procedures different from those recommended in item "Use
should not be hydrated before the use. It should be taken directly to the
recipient surgical bed.
SPECIAL CONDITIONS FOR THE
PRODUCT’S STORAGE AND TRANSPORTATION, CONSERVATION AND/OR HANDLING
and transport the product away from direct sunlight, and from heat.
(temperature between -5 and 40°C) and humidity.
Keep the packaging sealed until its utilization time. 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.
case of any alteration in the Hydroxyapatite characteristic that might have mischaracterized it, please discard it according to the applicable legislation
for hospital waste, or return the damaged packages to the factory, including