Keywords
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Keywords
Moldble allogeneic bone grafting materialNon-paying medical devicesNo need for tissue transplant resultsUse raw materials based on AATB
Technical Data
Ulnar fracture/18y male, compound fracture of distal radius and ulnar shaft [Related Clinical Cases]
Humerus fracture/36y female, fracture of distal humerus [Related Clinical Cases]
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Intended Use
This product is a bone graft material intended for implantation and is used to fill and replace bone tissue defects when applied to surgical bone defect sites.
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Preoperative Preparation
1) Verify the product expiration date and packaging condition prior to use. Do not use the product if the packaging is damaged or if the expiration date has passed.
2) This product shall be used only by qualified healthcare professionals in accordance with applicable regulations and must not be used for purposes other than its intended use.
3) Review the patient's medical history and radiographic examinations (e.g., X-rays) to evaluate indications and identify any potential contraindications. -
Directions for Use
1) Open the package using aseptic technique and transfer the contents into a sterile container.
2) Add the recommended amount of sterile saline solution or the patient's blood (including bone marrow aspirate concentrate).
3) Note: Follow the hydration volume specified in the Product Usage Guide.
4) Using sterile instruments, thoroughly mix the powder and liquid for at least 30 seconds until a homogeneous putty consistency is achieved.
5) Do not immerse the shaped graft material in solution after preparation, as this may cause dissolution of the carrier matrix. -
Storage and Expiration date
Store at room temperature (1–30°C). Avoid direct sunlight and storage in hot or humid environments.
This product is intended for single use only. Any unused remaining material shall be discarded immediately following biomedical waste regulations and must not be reused.
The shelf life of this product is 3 years from the date of manufacture (please refer to the packaging for details). -
Precautions
1) Although this product has undergone rigorous donor screening and sterilization processes, the risk of transmission of infectious agents, including viruses or prions (e.g., Creutzfeldt–Jakob Disease [CJD]), cannot be completely eliminated due to the inherent nature of human-derived tissues.
2) The carrier material (cellulose) in this product may absorb body fluids and expand in volume. When used in or near the spinal canal or nerve roots, excessive filling may exert expansion pressure, leading to nerve compression, neurological deficits, or localized pain. Use with caution.
3) This product is not intended to provide load-bearing support. In areas requiring structural stability, such as fracture sites or interbody spinal fusion procedures, it must be used in conjunction with appropriate rigid internal fixation devices (e.g., screws, plates, or cages).
4) Do not re-sterilize this product. Re-sterilization may alter the physical properties of the carrier, resulting in loss of viscosity and the generation of potentially toxic degradation products.
5) This product is intended solely for implantation into bone defect sites. Administration by any other route, including oral administration, intramuscular injection, subcutaneous injection, or intravenous injection, may cause inflammatory reactions and, in severe cases, may result in thrombosis and death.
Manufacturer
MedPark Co., Ltd.|#1007, #1009, ACE High-Tech City 2, 25 Seonyu-ro 13-gil, Yeongdeungpo-gu, Seoul, Republic of Korea | TEL: +82-2-554-8776
Sepcifications