GRAFTON DBM MATRIX STRIPS (DEVICE 1)

Additional Manufacturer Narrative

ALL DONOR AND MFG RECORDS RELATIVE TO THE SUBJECT GRAFTS WERE REVIEWED AND INDICATED THAT THE GRAFTS COMPLIED WITH OSTEOTECH¿S RELEASE CRITERIA AND MET ALL PRODUCT SPECS. THERE WERE NO DEFICIENCIES, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THESE GRAFTS. TO DATE, NO ADD¿L REPORTS OF THIS NATURE HAVE BEEN RECEIVED RELATIVE TO ANY OTHER PRODUCTS PRODUCED FROM THESE DONOR TISSUES. OSTEOTECH¿S MEDICAL DIRECTOR HAS MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO CONTACT THE SURGEON FOR FURTHER INFO, HOWEVER, NO ADD¿L INFO IS AVAILABLE AT THIS TIME. OSTEOTECH¿S MEDICAL DIRECTOR HAS REVIEWED THE CASE AND CONCLUDED THAT THERE IS NO EVIDENCE TO INDICATE ANY PROBLEM WITH THE PRODUCT. ADD'L LOT# OTSCT0713164035, EXPIRATION DATE: 04/01/2012.

Description of Event or Problem

(B)(6) YEAR OLD, FEMALE, PT, UNDERWENT A RESECTION OF AN ILIAC UNICAMERAL BONE CYST UTILIZING FOUR-STEP CURETTAGE, HIGH SPEED BURRING, CAUTERIZATION AND PHENOLIZATION OF THE INTERIOR WALL OF THE CYST. THE DEFECT WAS GRAFTED USING AUTOGENOUS BONE MARROW GRAFT COMBINED WITH ¿ALLOGRAFT ALLOMATRIX STRIP (ASSUMED TO BE GRAFTON MATRIX STRIP) AND GRAFTON PASTE RECONSTRUCTION.¿ THE VOLUME OF EACH PRODUCT THAT WAS IMPLANTED IS UNK. ON F/U VISITS (ELAPSED TIME UNK) THE PT WAS HAVING PAIN, AND POST-OPERATIVE IMAGING (ELAPSED TIME UNK) ¿DID NOT SHOW THAT THE BONE GRAFT WAS GETTING INCORPORATED INTO THE PT BONE¿. THE PT WAS DIAGNOSED WITH POSSIBLE RECURRENCE OF THE CYST AND UNDERWENT A SECOND SURGERY ON (B)(6) 2010, WITH FROZEN SECTION AND CULTURE OF THE CYST. PATHOLOGY REPORT SHOWED ¿BONE GRAFT MATERIAL AND LOOSE FIBROUS STROMA WITH RARE AGGREGATES OF LYMPHOCYTES.¿ THERE WAS NO EVIDENCE OF INFECTION ON GRAM STAIN AND CULTURE AND NO RECURRENCE OF THE CYST. SURGEON CONCLUDED THAT THERE MAY HAVE BEEN ¿A PROBLEM WITH THE BONE GRAFT INCORPORATION FROM THE FIRST OPERATION.¿