Description of Event or Problem · 1
PT HAD NEURO SURGERY FOR A CHIARI MALFORMATION. A DURAL GRAFT WAS UTILIZED TO EXPAND THE POSTERIOR ASPECT OF THE POSTERIOR FOSSA. THE DURAL PRODUCT UTILIZED WAS "DURAGEN," A RESORBABLE DURAL REGENERATION MATRIX BY INTERGA LIFESCIENCES CORP. PT WAS DISCHARGED HOME 8 DAYS LATER IN STABLE CONDITION. FIVE DAYS LATER, PT PRESENTED TO THE ED WITH SEVERE HEADACHES AND PHOTOPHOBIA, PT WAS READMITTED TO THE HOSP. FOUR DAYS LATER, PT RETURNED TO SURGERY FOR A SUSPECTED CSF LEAK. DURING SURGERY, THE DURAL GRAFT WAS INSPECTED AND MULTIPLE TEARS WERE IDENTIFIED WITH MULTIPLE AREAS OF SPINAL FLUID LEAK INTO THE SURGICAL FIELD. ATTEMPTS TO REPAIR THE AREAS WHERE THE GRAFT HAD BECOME DEHISCENT FAILED DUE TO THE FRAGILITY OF THE GRAFT. GRAFT WAS REMOVED AND REPLACED WITH BOVINE PERICARDIUM AS THE DEFINITIVE GRAFT. CULTURES WERE TAKEN OF THE ORIGINAL DURAL GRAFT. RESULTS WERE POSITIVE FOR STAPH. THIS WAS THE FIRST TIME WE HAD USED THE DURAGEN DURAL GRAFT, UNK IF THIS IS A PRODUCT DEFECT.