The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure is (or may be) needed.Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.This report is number 2 of 2 mdr's filed for the same patient (reference 1825034-2015-04326 / 2016-01538).Product location unknown.
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