- OSTEOSYNT® must be prepared in site, applied to the healthy bleeding bone after cleaning and removal of the defective bone;
- It should preferably be combined with the patient's autogenous medular blood and/or autogenous medular bone.
- The product can also be used pure or isolate.
- OSTEOSYNT® can also be used in combination with fibrin, platelet concentrates, cell concentrates and blood products, and/or adequate binding substances which allow its proper modelling according to indication;
- For its characteristics and physiochemical properties the product can be used as a conducer and releaser of such drugs as antibiotics, proteins, chemotherapeuticals and others;
- OSTEOSYNT® characteristic is to form a BONE MORPHOGENETIC COMPLEX.
For a faster recovery and better results the following is recommended:
- Association of medular blood puncture (up to 3.5 cm3 or 3.5ml each puncture) with OSTEOSYNT® in the 5g bottle;
- Shake the bottle for some four or five minutes. One gram of OSTEOSYNT® immediately absorbs approximately 0.7cm3 of medular blood, which contains all the autogenous ingredients necessary for the process to complete;
- Preferably puncture the iliac or femur as they contain a higher level of the substances necessary for the process;
- The process requires a compact filling of the area, as well as its adequate containment and stabilization.
- Surgical use of OSTEOSYNT® must be restricted to qualified professionals with expertise in the surgical techniques and procedures indicated once the inadequate application of the product may not reach the results expected and/or trigger migration of the product.
- Presurgical evaluations, adequate selection of materials, use of compatible surgical techniques and procedures as well as post-surgical control are crucial to produce the desired results.
- Unused products opened during surgery must be immediately disposed of in acordance with the current legislation about hospital waste.
- Out-of-date and unused products with a broken seal must be destroyed before disposal.
- STERILE ETHILEN OXIDE (ETO).
- SINGLE USE.
- DO NOT REUSE.
- DO NOT RESTERILIZE.
- DO NOT USE IF CONTAINER SEAL IS BROKEN OR AFTER EXPIRATION DATE.
- STORE AT ROOM TEMPERATURE
IMPORTANT: three conditions must be present to ensure new bone formation:
- Morphogenetic proteins (BMP´s);
- Specific cells (mother cells).
- Absence of any of those conditions shall compromise the results.
Complications such as particle extrusion, migration of granules, dehiscence of soft tissues, delayed scarring associated to failure to apply surgical techniques and procedures do not necessarily compromise clinical results. This product is radiopaque, visible under X-ray.
To patients: Physical activities are restricted during the recovery period and must be evaluated according to the type of surgery, extent of lesion and area of application of the product. Deambulation may take from three to six months, provided that professional prescriptions concerning the length of time required for natural organic neo-formation of the tissue are followed.