The device history record was reviewed, and no irregularities were noted.Therefore, it is not considered to be a problem in product specifications.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 patient underwent periarticular knee osteotomy with a bone plate, bone screws and this product (bone void filler).Pigmentation was observed after surgery.Approximately 6 months after the surgery, irrigation (of the wound) were performed, and the bone plate and screws were removed.
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