ROOT CAUSE IS UNDETERMINED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CONCLUSION CANNOT BE MADE AS TO THE CAUSE OF THE HERNIA RECURRENCE. AS REPORTED THIS PATIENT HAS A COMPLEX MEDICAL/SURGICAL HISTORY INCLUDING MULTIPLY ABDOMINAL SURGERIES. ADDITIONALLY, AS REPORTED THE MESH WAS NOT PLACED WITHIN AT LEAST A 5MM MARGIN OVER THE DEFECT AS SUCH THIS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE HERNIA RECURRENCE. THE CAUSE THE HERNIA RECURRENCE IS UNKNOWN HOWEVER, PATIENT COMORBITIES AND PLACEMENT OF THE MESH DURING THE INDEX PROCEDURE MAY HAVE CONTRIBUTED TO THE HERNIA RECURRENCE. THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE STATES, "TO PREVENT RECURRENCES WHEN REPAIRING HERNIAS, THE PHASIX MESH MUST BE LARGE ENOUGH TO PROVIDE SUFFICIENT OVERLAP BEYOND THE MARGINS OF THE DEFECT. CAREFUL ATTENTION TO MESH FIXATION PLACEMENT AND SPACING WILL HELP PREVENT EXCESSIVE TENSION OR GAP FORMATION BETWEEN THE MESH AND FASCIAL TISSUE." TO DATE THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 121 UNITS RELEASED FOR DISTRIBUTION IN JANUARY, 2014. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL SUBMITTED.
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Patient 1
IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2014 THE SUBJECT PATIENT UNDERWENT REPAIR OF A MIDLINE HERNIA UTILIZING BARD PHASIX MESH. AN ONLAY PLACEMENT WITHOUT COMPONENT SEPARATION TECHNIQUE WAS PERFORMED. THE HERNIA DEFECT MEASURED 15CM IN LENGTH AND 12CM IN WIDTH. THIS PROCEDURE WAS PERFORMED IN CONJUNCTION WITH CREATION OF BILATERAL SUBCUTANEOUS TISSUE FLAPS. PERIMETER FIXATION WAS COMPLETED WITH ABSORBABLE MONOFILAMENT SUTURE WITH 12 FIXATION POINTS. THE FASCIA WAS RE-APPROXIMATED AND THE SKIN WAS FULLY CLOSED. ON (B)(6) 2017 THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THE RECURRENCE HAS BEEN ASSESSED PER THE CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED BY THE CLINICIAN AS MODERATE SEVERITY WITH AN ONGOING RESOLUTION DATE. NO ACTION HAS BEEN TAKEN. AS REPORTED THAT A PROTOCOL DEVIATION OCCURRED AT THE TIME OF IMPLANT ON (B)(6) 2014 AS THE HERNIA DEFECT MEASURED 15CMX12CM AND PHASIX MESH USED TO TREAT THE HERNIA MEASURED 15.2CM X 20.3CM WAS NOT WITHIN GUIDELINES FOR AT LEAST 5CM MARGIN OVER DEFECT