GRAFTON DBM MATRIX STRIPS

Additional Manufacturer Narrative

ALL DONOR AND MANUFACTURING RECORDS RELATIVE TO THE SUBJECT GRAFT WERE REVIEWED AND INDICATED THAT THE GRAFT WAS MANUFACTURED PER PROCEDURE, COMPLIED WITH OSTEOTECH'S RELEASE CRITERIA AND MET ALL PRODUCT SPECIFICATIONS. THERE WERE NO DEFICIENCIES, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THIS GRAFT. TO DATE, NO ADDITIONAL REPORTS OF THIS NATURE HAVE BEEN RECEIVED RELATIVE TO ANY OTHER PRODUCTS PRODUCED FROM THIS DONOR TISSUE. OSTEOTECH'S MEDICAL DIRECTOR HAS REVIEWED THE MANUFACTURING AND HOSPITAL RECORDS AND CONCLUDED THAT THERE IS NO EVIDENCE TO INDICATE THAT THE SUBJECT GRAFT WAS THE SOURCE OF THE PATIENT'S INFECTION. THE (B)(6) THAT PROVIDED THE TISSUE TO OSTEOTECH FOR PROCESSING WAS NOTIFIED OF THIS REPORT. THEY HAVE NOT RECEIVED ANY ADDITIONAL REPORTS OF THIS NATURE INVOLVING ANY OTHER TISSUES DISTRIBUTED FROM THIS DONOR.

Description of Event or Problem

ON (B)(6) 2009, PATIENT UNDERWENT AN ANTERIOR/POSTERIOR SPINAL FUSION WITH REPOSITIONING OF PREVIOUSLY PLACED SUBCUTANEOUS RODS. SHE WAS DISCHARGED FROM THE HOSPITAL ONE WEEK LATER ((B)(6) 2009) AND WAS READMITTED BACK TO THE HOSPITAL ON (B)(6) 2009 WITH AN INFECTED WOUND. ON (B)(6) 2009, SHE UNDERWENT IRRIGATION AND DEBRIDEMENT (X2) OF THE WOUND, AT WHICH TIME SURGEON REMOVED ANY LOOSE ALLOGRAFT, AND WAS DISCHARGED ON (B)(6) 2009. PATIENT WAS TREATED WITH THE FOLLOWING COURSES OF ANTIBIOTICS: (B)(6) 2009 VANCOMYCIN 270MG Q8H IV, (B)(6) 2009 CEFAZOLIN (ANCEF) 442 MG Q8H IV, (B)(6) 2009 VANCOMYCIN 270 MG PREOP, THEN Q8H IV, (B)(6) 2009 NITROFURANTOIN (FURADANTIN) 5 MG/DL LIQUID 35 MG, (B)(6) 2009 VANCOMYCIN 315 MG Q8H IV, (B)(6) 2009 VANCOMYCIN 265 MG Q8H IV, (B)(6) 2009 MOXIFLOXACIN (AVELOX) 144 MG IV Q D, (B)(6) 2009 MOXIFLOXACIN 8MG/KG PO Q D, (B)(6) 2009 - (B)(6) 2010 CIPROFLOXACIN (CIPRO) 500 MG BID PO. AS REPORTED BY THE HOSPITAL, AS OF (B)(6) 2010, THE PATIENT'S WOUND HAD HEALED AND SHE WAS OFF OF ALL ANTIBIOTICS.