MegaDBM®
MegaDBM®
Medical Device
| Principle of action | This product is a mixture of HA-CMC gel in the demineralized bone matrix, and the DBM mixed with the gel fills and replaces the area where bone defects occur. |
| Purpose of use |
This is an implant containing biologically derived materials to replace a bone when it is lost due to injury or osteoporosis. |
| Storage method and Shelf life | Room temperature (1~30 ℃), 3 years from MFD |
| Precautions for use |
A. General Notices 1) The instruction for use and precautions shall be read and unless the user follow the instruction for use and precautions, performance, infection, or side effects may arise. 2) It shall be used only by medical professionals and be used only as intended. 3) If side effects are discovered in the transplanted patient, immediately report it to the Ministry of Food and Drug Safety, and the hospital and doctor who performed the transplant will take necessary medical measures for the patient. 4) Prior to use, if the recipient has an allergic reaction to the reagents and solutions used in the preparation of this product, it should not be used. According to a medical professional’s opinion, the use of the product is prohibited if there is a possibility that the patient may cause side effects after implantation of the product. This is especially true for weakened patients with immune systems. B. Notices regarding adverse events after use of medical device, deadly side effects or accidents due to careless handling 1) The user's arbitrary reuse may lead to sterilization and microbial contamination of the product, and if the contaminated product is transplanted, inflammation, fever, edema, and allergy may occur. 2) If the product has expired, the use of the product is prohibited. If a product whose expiration date has passed is transplanted, inflammation, fever, and edema may occur. C. Use for pregnant women, lactating women, childbearing women, newborns, infants, children, the elderly 1) There are no clinical data for this product for pregnant women or women of childbearing potential and lactating women. Therefore, its use is not recommended for safety reasons. 2) Since clinical trials have not been conducted, and thus, newborns, infants, children and the elderly is not recommended to use. D. Notices in application 1) This product is a Gamma sterilized product and must not be re-sterilized, and once opened, the product must not be re-sterilized and reused. 2) Each individually packaged product should only be used on one patient. E. Requirements for prevention of accidents 1) Since this product is manufactured through a GMP process certified by the Ministry of Food and Drug Safety, it is recommended to use this product in an environment (sterile environment) and facilities similar to the manufacturing environment when using this product. 2) The affected area where the transplantation takes place shall be kept non-contaminated. |
