MegaDBM® S
MegaDBM® S
Medical Device
| Principle of action |
This product contains hyaluronic acid (HA)-carboxymethylcellulose (CMC) gel in a mixture consisting of demineralized bone matrix (DBM) and bone mineral powder. It fills and replaces the area where bone defects have occurred, and has osteoinductive ability. |
| 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 |
1) Room temperature (1~30’C) 2) Avoid direct sunlight and high temperature and high humidity 2 years from the date of manufacture |
| 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. 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. 3) Accessories (auxiliary caps) must not come into direct contact with the human body when in use. 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. |
