Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the 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 12 states, "early or late postoperative infection and allergic reaction." review of sterilization certification confirms device was sterilized in accordance with iso (b)(4).This report is number 7 of 7 mdrs filed for the same patient (reference 1825034-2016-05042, 1825034-2016-05048).
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