Pure Phase Beta-Tricalcium Phosphate
Bone Graft Syringe
SynthoGraft® Considerations
Indications and Usage:
- SynthoGraft® is designed for the filling and/or reconstruction of a traumatic or degenerative multi-walled bone defect, augmentation of the sinus floor, augmentation of alveolar ridges, filling of periodontal or other alveolar bone defects, tooth sockets, and osteotomies, and preservation of the alveolus for the preparation of an implant site.
Warnings:
- SynthoGraft® should be used only by or under the supervision of trained personnel with experience with the surgical techniques associated with biomaterials.
- SynthoGraft® is packaged and sterilized via gamma irradiation for single use only.
- Do not apply SynthoGraft® dry. It must be wetted with the patient’s blood.
- Do not saturate SynthoGraft® with any liquid other than the patient’s blood.
- Do not re-sterilize SynthoGraft®.
- Discard any unused SynthoGraft®t granulate. Re-use of SynthoGraft® may cause adverse reactions, including, but not limited to, infection, inflammation, or other injury.
- SynthoGraft® is not intended for immediate loading.
- Do not overfill defect site.
- Secure SynthoGraft® to prevent migration of materials.
- Do not use if package has been opened, damaged, or if the expiration date has passed.
- Do not compromise blood supply to the defect area.
- Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established, if applicable.