GRAFTON DBM MATRIX STRIPS

Additional Manufacturer Narrative

ALL MANUFACTURING RECORDS FOR THE SUBJECT GRAFT WERE REVIEWED, AND INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL SPECIFICATIONS. ALL CRITICAL PROCESSING PARAMETERS WERE MET, AND THERE WERE NO IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THE PRODUCT. (B)(6) MEDICAL DIRECTOR HAS REVIEWED THE CASE AND STATES THAT THERE IS NO EVIDENCE TO INDICATE THAT THE GRAFTING MATERIAL WAS THE PROXIMATE CAUSE OF THE PATIENT'S ADVERSE REACTION. IN ADDITION, THE TREATING SURGEON STATED THAT, IN HIS OPINION, THE GRAFTING MATERIAL DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S ADVERSE REACTION. THERE HAVE BEEN NO ADDITIONAL REPORTS OF THIS NATURE ASSOCIATED WITH PRODUCTS PRODUCED FROM THIS DONOR. THIS REPORT WAS COMPLETED USING THE INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE REPORTER.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2011, PATIENT UNDERWENT SURGERY FOR A CERVICAL SPONDYLOTIC MYELOPATHY (STATUS POST LAMINECTOMY AND FUSION) WITH INSTRUMENTATION AND FUSION OF THE SPINE FROM C3 TO T1. DEMINERALIZED BONE GRAFTING MATERIAL WAS IMPLANTED DURING THE PROCEDURE. PATIENT WAS DISCHARGED ON (B)(6) 2011. PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2011 DUE TO SUPERFICIAL WOUND DEHISCENCE AND POSSIBLE INFECTION. ON (B)(6) 2011, PATIENT UNDERWENT SURGERY FOR AN EXPLORATION OF THE WOUND, DEBRIDEMENT AND RECLOSURE. GRAFTING MATERIAL WAS NOT EXPLANTED. PATIENT WAS PLACED ON ANTIBIOTICS (VANCOMYCIN), AND WAS DISCHARGED ON (B)(6) 2011, AT WHICH TIME HIS STATUS WAS "IMPROVING."