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Patient 1
AS REQUESTED THE SURGEON WAS PROVIDED WITH A DOCTOR TO DOCTOR CONSULT. BASED ON INFORMATION OBTAINED FOLLOWING THE CONSULT IT APPEARS THAT THE PATIENT WAS EXPERIENCING AN EXAGGERATED FOREIGN BODY RESPONSE, IT ALSO APPEARS THAT THE GRAFT WAS NOT PLACED FLAT WHICH COULD CONTRIBUTE TO THE REPORTED INCORPORATION OF THE GRAFT. THE PRECAUTION SECTION OF THE IFU STATES, PLACE DEVICE IN MAXIMUM POSSIBLE CONTACT WITH HEALTH, WELL VASCULARIZED TISSUE TO PROMOTE CELL INGROWTH AND TISSUE REMODELING. INFLAMMATION AND ALLERGIC REACTION OR HYPERSENSITIVITY TO DEVICE MATERIALS ARE LISTED IN THE ADVERSE REACTION SECTION OF THE IFU AS POSSIBLE COMPLICATIONS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT CODE AND LOT NUMBER OF THE XENMATRIX AB GRAFT, HOWEVER THE USER WAS NOT WILLING TO PROVIDE THIS INFORMATION. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. BASED ON THE INFORMATION PROVIDED, NO DEFINITIVE CONCLUSION CAN BE MADE AS TO WHY THE GRAFT DID NOT INCORPORATE. SHOULD ADDITIONAL DETAILS BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. REMAINS IMPLANTED.