Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, "early or late postoperative, infection, and allergic reaction." review of sterilization certification confirms device was sterilized in accordance with (b)(4).Surgeon didn't approve for return.
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