DBX PUTTY , 5CC (DEMINERALIZED BONE MATRIX)

Additional Manufacturer Narrative

DONOR ELIGIBILITY WAS DETERMINED BY THE MEDICAL DIRECTOR ON (B)(6) 2015. DONOR COMPLIES. RELEVANT COMMUNICABLE INFECTIOUS DISEASE SEROLOGY TESTING WERE NONREACTIVE. THE BATCH RECORD REVIEW ASSOCIATED WITH THE PRODUCTION OF THE COMPLAINT UNIT SHOWED NO EVIDENCE OF ERRORS, DISCREPANCIES, OMISSIONS OR CGTP VIOLATIONS. UNITS ASSOCIATED WITH THIS DONOR WERE RELEASED AS PER MTF SPECIFICATIONS. TISSUE IN-PROCESS BIOBURDEN AND FINAL STERILITY CULTURES ARE NEGATIVE FOR GROWTH. ENVIRONMENTAL DATA WAS REVIEWED. ALL LOCATIONS WERE IN CONTROL. THERE HAVE BEEN NO OTHER ADVERSE EVENTS RECEIVED FOR THIS DONOR. THE CASE DETAILS AND INVESTIGATION FINDINGS WERE REVIEWED BY MTF'S MEDICAL DIRECTOR WHO FOUND NO EVIDENCE TO INDICATE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. DEVICE IMPLANTED.

Description of Event or Problem

IT WAS REPORTED PATIENT EXPIRED TWO DAYS POST-SURGERY. PATIENT UNDERWENT A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (TPLIF) FROM L5-S1 FOR CENTRAL STENOSIS ON (B)(6) 2016. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO COMPLICATIONS. PATIENT WAS LAST CHECKED AT NIGHT ON (B)(6) 2016 AND WAS REPORTED AS STABLE. THE NURSE REVISITED THE PATIENT IN THE MORNING (UNKNOWN TIME) ON (B)(6) 2016 AND PATIENT WAS CODED. PATIENT IS AN ORGAN DONOR AND HIS HEART AND TISSUES WERE HARVESTED. AUTOPSY RESULTS HAVE NOT BEEN PROVIDED TO SURGEON AT THIS TIME. SURGEON SUSPECTED HEART ATTACK HOWEVER, IT IS UNKNOWN IF PATIENT HAD PRE-EXISTING HEART ISSUES." REPORTER STATES AUTOPSY REPORT WILL BE AVAILABLE AT A LATER DATE.

Additional Manufacturer Narrative

DONOR ELIGIBILITY WAS DETERMINED BY THE MEDICAL DIRECTOR ON 4/21/2015. DONOR COMPLIES. RELEVANT COMMUNICABLE INFECTIOUS DISEASE SEROLOGY TESTING WERE NONREACTIVE. THE BATCH RECORD REVIEW ASSOCIATED WITH THE PRODUCTION OF THE COMPLAINT UNIT SHOWED NO EVIDENCE OF ERRORS, DISCREPANCIES, OMISSIONS OR CGTP VIOLATIONS. UNITS ASSOCIATED WITH THIS DONOR WERE RELEASED AS PER MTF SPECIFICATIONS. TISSUE IN-PROCESS BIOBURDEN AND FINAL STERILITY CULTURES ARE NEGATIVE FOR GROWTH. ENVIRONMENTAL DATA WAS REVIEWED. ALL LOCATIONS WERE IN CONTROL. THERE HAVE BEEN NO OTHER ADVERSE EVENTS RECEIVED FOR THIS DONOR. THE CASE DETAILS AND INVESTIGATION FINDINGS WERE REVIEWED BY MTF'S MEDICAL DIRECTOR WHO FOUND NO EVIDENCE TO INDICATE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. ON 10/4/2015: DESPITE NUMEROUS ATTEMPTS, AN AUTOPSY REPORT WAS UNABLE TO BE OBTAINED. A TOTAL OF (B)(4) DBX UNITS WERE PRODUCED FROM DONOR (B)(6), ALL WERE DISTRIBUTED. THERE ARE 12 TISSUE TRACE RECORDS ON FILE FOR THE DBX UNITS. AS PER MTF'S MEDICAL DIRECTOR (DR. (B)(6)): "REPORT OF SUDDEN CARDIAC DEATH 2 DAYS POST OP, NO REPORT OF INFECTION, DONOR MET ALL CRITERIA, NO EVIDENCE TO LINK CAUSE OF DEATH TO GRAFT." CONCLUSION: THE CASE DETAILS AND INVESTIGATION FINDINGS WERE REVIEWED BY MTF'S MEDICAL DIRECTOR WHO FOUND NO EVIDENCE TO INDICATE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THIS INVESTIGATION IS CONSIDERED CLOSED.

Description of Event or Problem

IT WAS REPORTED PATIENT EXPIRED TWO DAYS POST-SURGERY. PATIENT UNDERWENT A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (TPLIF) FROM L5-S1 FOR CENTRAL STENOSIS ON (B)(6) 2016. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO COMPLICATIONS. PATIENT WAS LAST CHECKED AT NIGHT ON (B)(6) 2016 AND WAS REPORTED AS STABLE. THE NURSE REVISITED THE PATIENT IN THE MORNING (UNKNOWN TIME) ON (B)(6) 2016 AND PATIENT WAS CODED. PATIENT IS AN ORGAN DONOR AND HIS HEART AND TISSUES WERE HARVESTED. AUTOPSY RESULTS HAVE NOT BEEN PROVIDED TO SURGEON AT THIS TIME. SURGEON SUSPECTED HEART ATTACK HOWEVER, IT IS UNKNOWN IF PATIENT HAD PRE-EXISTING HEART ISSUES." REPORTER STATES AUTOPSY REPORT WILL BE AVAILABLE AT A LATER DATE.