XEMPLIFI DBM PUTTY

Additional Manufacturer Narrative

ACCORDING TO THE REPORT FROM THE DISTRIBUTOR, AN INFECTION HAD MATERIALIZED 6 WEEKS POST SURGERY. THE TISSUE BASED MEDICAL DEVICE IS ASEPTICALLY PROCESSED, FREEZE DRIED, AND TERMINALLY STERILIZED VIA ELECTRON BEAM IRRADIATION. THE 77 TOTAL TISSUE LOTS WERE PRODUCED FROM DONOR (B)(6): 25 DEVICE LOTS, 45 BONE GRAFTS, 7 SOFT TISSUE GRAFTS. THE 67 TOTAL LOTS WERE DISTRIBUTED: 21 DEVICE LOTS WERE DISTRIBUTED, 4 USED AS QC SAMPLES; 39 BONE LOTS WERE DISTRIBUTED, 6 WERE DISCARDED PRIOR TO DISTRIBUTION; ALL 7 SOFT TISSUE LOTS WERE DISTRIBUTED. ONE LOT OF TISSUE BASED DEVICE WAS IMPLANTED INTO THE PATIENT ASSOCIATED WITH THIS ADVERSE EVENT 156410-6517. ALLOSOURCE HAS RECEIVED NO ADDITIONAL REPORTS OF ADVERSE REACTIONS OR ADVERSE EVENTS ASSOCIATED WITH THE OTHER 66 DISTRIBUTED LOTS. THE 45 TOTAL TISSUE LOTS WERE PRODUCED FROM DONOR (B)(6): 25 DEVICE LOTS, 20 BONE GRAFTS. THE 41 TOTAL LOTS WERE DISTRIBUTED: 20 DEVICE LOTS, 4 USED AS QC SAMPLES, 1 DISCARDED PRIOR TO DISTRIBUTION; 16 BONE LOTS WERE DISTRIBUTED, AND 4 WERE QUARANTINED. THREE LOTS OF TISSUE BASED DEVICE WERE IMPLANTED INTO THE PATIENT ASSOCIATED WITH THIS ADVERSE EVENT 164682-6505, 164682-6509, 164682-6512. ALLOSOURCE HAS RECEIVED NO ADDITIONAL REPORTS OF ADVERSE REACTIONS OR ADVERSE EVENTS ASSOCIATED WITH THE OTHER 38 DISTRIBUTED LOTS.

Description of Event or Problem

FOUR LOTS OF XEMPLIFI DBM PUTTY 10 CC, FROM TWO DONORS, MANUFACTURED BY ALLOSOURCE WERE IMPLANTED INTO A PATIENT ON (B)(6) 2017. ON (B)(6) 2017 THE SURGEON NOTIFIED THE PRIVATE LABEL DISTRIBUTOR THAT HE WAS WORRIED THAT THE PATIENT GOT A STAPH INFECTION FROM THE "BONE GRAFT". ALLOSOURCE RECEIVED NOTIFICATION OF THE INCIDENT ON (B)(4) 2017. THE FOUR LOTS OF TISSUE BASED MEDICAL DEVICES REMAIN IN THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SURGEON TO DATE. FOUR SEPARATE ADVERSE EVENT REPORTS ARE BEING SUBMITTED FOR THE EVENT ASSOCIATED WITH THIS PATIENT: 3000215346-2017-00009, 3000215346-2017-00010, 3000215346-2017-00012.