DBX PUTTY, 10CC

Additional Manufacturer Narrative

THE DONOR AND PROCESSING BATCH RECORDS FOR DONOR (B)(6) WERE RE-REVIEWED. THE DONOR WAS APPROPRIATELY SCREENED AND TESTED IN ACCORDANCE WITH MTF'S DONOR RELEASE CRITERIA. THE SUBJECT ALLOGRAFT MET SPECIFICATION AND WAS APPROPRIATELY RELEASED FOR DISTRIBUTION AND TRANSPLANTATION. THE COMPLAINT UNIT WAS NOT RETURNED TO MTF FOR EVALUATION AS THE GRAFT WAS IMPLANTED. THERE HAVE BEEN NO ADDITIONAL COMPLAINTS OR ADVERSE EVENTS RECEIVED FOR DONOR (B)(6). A TOTAL OF 27 DBX PUTTY UNITS WERE PRODUCED FROM THIS DONOR, ALL OF WHICH HAVE BEEN DISTRIBUTED. THERE ARE 21 TISSUE TRACE RECORDS ON FILE; THERE IS A RECORD ON FILE IS FOR THE COMPLAINT UNIT. ENVIRONMENTAL DATA FOR THE LOCATIONS SHOWS THAT THE LOCATIONS WERE IN CONTROL. AS PER MTF'S MEDICAL DIRECTOR (DR. (B)(6)), "REPORT OF POS (B)(6) TEST IN PATIENT WHO RECEIVED DBX IMPLANT WEEKS BEFORE. ATTEMPTS TO GET FURTHER INFO ON THIS PATIENT ABOUT HOW LONG THEY WERE KNOWN TO BE POS OR WHAT SIGNS AND SYMPTOMS WERE PRESENT OR WHAT RISK BEHAVIORS WERE KNOWN WERE UNSUCCESSFUL. IN ADDITION, (B)(6) IS WIDELY PREVALENT TO OTHERWISE WELL PATIENTS UNDERGOING SURGERY. AND DBX IS HIGHLY PROCESSED BY TECHNIQUES VALIDATED TO INACTIVATE VIRUSES INCLUDING (B)(6). THUS THERE IS NO EVIDENCE TO LINK THE GRAFT TO THE PATIENT'S TEST RESULT." THIS IS INVESTIGATION IS CLOSED.

Description of Event or Problem

ON 1/27/2017, MTF WAS NOTIFIED THAT A PATIENT OF DR. (B)(6) WHO WAS IMPLANTED WITH DBX THREE WEEKS AGO TESTED (B)(6).

Additional Manufacturer Narrative

IMPLANTED.

Description of Event or Problem

ON (B)(6) 2017, MTF WAS NOTIFIED THAT A PATIENT OF DR. (B)(6) WHO WAS IMPLANTED WITH DBX THREE WEEKS AGO TESTED (B)(6) FOR (B)(6).