Description of Event or Problem · 1
ENDURA NO-REACT DURAL SUBSTITUTE MANUFACTURED BY SHELHIGH, INC. IS SUBJECT TO A RECALL. THE PHYSICIAN REPORTED AN INCIDENT NOT PREVIOUSLY REPORTED WITH A PATIENT THAT SHE USED THE ENDURA NO-REACT DURAL SUBSTITUTE DURING A CRANIOTOMY PROCEDURE FOR A TUMOR. PATIENT HAD AN INFECTION WITH AN UNUSUAL ORGANISM E COLI. ADDITIONAL INFORMATION WAS PROVIDED BY THE USER FACILITY TO INTEGRA TECHNICAL SERVICES. THE TECHNICIAN REPORTED IN RESPONSE TO THE RECALL OF ENDURA NO-REACT DURAL SUBSTITUTE MANUFACTURED BY SHELHIGH, INC ON THE DEVICE THAT WAS NOT PREVIOUSLY REPORTED. PATIENT HAD A LARGE BRAIN TUMOR REQUIRING A CRANIOTOMY. THE INITIAL SURGERY WAS 2007. WHEN THE PT RETURNED A FEW DAYS LATER, THE PT DEVELOPED A SERIOUS INFECTION WHICH LATER DETERMINED TO BE CAUSED BY A GRAM NEGATIVE E COLI ORGANISM. THE PATIENT WAS GIVEN IV ANTIBIOTICS AND A SECOND SURGERY OCCURRED ON TEN DAYS LATER. THE SECOND SURGERY REVEALED LARGE AMOUNTS OF PUS. AFTER THE ORIGINAL ENDURA NO-REACT DURAL SUBSTITUTE WAS REMOVED AND THE WOUND CLEANED, A SECOND PIECE OF ENDURA NO-REACT DURAL SUBSTITUTE WAS PLACED ON THE BRAIN. THE SECOND PIECE OF ENDURA NO-REACT DURAL SUBSTITUTE WAS FROM THE SAME LOT NUMBER AS THE FIRST PIECE USED. AS FAR AS THE PHYSICIAN IS AWARE, THE PATIENT IS NOW DOING FINE. THE FIRST PIECE OF ENDURA NO-REACT DURAL SUBSTITUTE WAS NOT SAVED FOR INVESTIGATION.