The device history record was reviewed, and no irregularities were noted.Because the device (referenced in this report) was not returned to olympus terumo biomaterials corp.For evaluation, the cause of the adverse event have not been specified.The osferion bone void filler package insert states in the following section: adverse events: fever, pain, local sensation, red flare, inflammation.This report is being submitted as a medical device report is an abundance of caution.
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A case treated with high tibial osteotomy (hto) during the operation: after osteotomizing the tibia, the surgeon in charge of the patient implanted a bone void filler (hereafter, this product), which was trimmed corresponding to the shape of the bone defect, and then fixed the osteotomized tibia with a metal plate and screws all of which are exclusively used for internal fixation.After the operation: when removing the surgical drain 24 hours after the surgery, the surgeon observed that exudate started oozing out from the surgical wound at around the level of the third screw counted from the most proximal screw.Postoperative course: afterwards no discharge of exudate was observed.The patient has not manifested any symptoms of infection such as redness and swelling.
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