GRAFTON

Additional Manufacturer Narrative

NO PRODUCTS WERE AVAILABLE FOR TESTING, ALL HAD PREVIOUSLY BEEN SOLD FROM STOCK OR IMPLANTED. REVIEW OF DONOR AND TISSUE SUITABILITY, PROCESSING AND STERILITY RECORDS WAS PERFORMED IN LIEU OF ACTUAL PRODUCT SAMPLING. ALL SUITABILITY, ENVIRONMENTAL AND STERILITY TESTING RECORDS COMPLIED WITH RELEASE REQUIREMENTS. NO INDICATION ORGANISM WAS PRESENT IN THE PRODUCT. NO OTHER EVENTS OF THIS NATURE REPORTED FOR THIS LOT. PRODUCT WAS APPROPRIATELY USED. INFECTION/ADVERSE EVENT MOST LIKELY DUE TO HOSPITAL-ACQUIRED ORGANISM. FOLLOW-UP WITH SURGEON WILL CONTINUE UNTIL INFORMATION REGARDING DATE INFECTION PRESENTED, COURSE OF TREATMENT, AND PATIENT OUTCOME ARE OBTAINED. REPORT TO BE UPDATED AT THAT TIME.

Description of Event or Problem

ON 12/15/07, DR REPORTED A POST-OPERATIVE INFECTION ON A PATIENT. PATIENT HAD A LUMBAR DECOMPRESSION PROCEDURE PERFORMED NINE MONTHS EARLIER. POST-OP, PATIENT DEVELOPED MRSE INFECTION (METHICILLIN, RESISTANT STAPH. EPIDERMIDIS). DATE PATIENT PRESENTED WITH INFECTION CURRENTLY NOT AVAILABLE. TREATMENT OF REPORTED INFECTION CURRENTLY NOT AVAILABLE. PATIENT CONDITION NOT CURRENTLY AVAILABLE. SURGEON WAS CONTACTED ON 12/17/07, 12/27/07, 01/02/08 AND 01/03/08 WITH NO RESPONSE.