FDA.reportPublic FDA data

MAUDE MDR 7158026

MDR report key
7158026
Report number
3000215346-2017-00008
Event key
0
Event type
3
Date of event
2017-08-17
Date received
2018-01-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. TREVOR WRIGHT
Address
6278 S. TROY CIRCLE CENTENNIAL CO 80111 US
Phone
720-720-7208
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1XEMPLIFI DBM PLUSBONE VOID FILLLERALLOSOURCEMBP8103.0210SR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-0201. O

Event Narratives#

N

Patient 1

ACCORDING TO THE REPORT FROM THE DISTRIBUTOR, AN INFECTION HAD MATERIALIZED 3 WEEKS POST SURGERY. THE TISSUE BASED MEDICAL DEVICE IS ASEPTICALLY PROCESSED, FREEZE DRIED, AND TERMINALLY STERILIZED VIA ELECTRON BEAM IRRADIATION. NINETY-TWO (92) TOTAL TISSUE LOTS WERE PRODUCED FROM DONOR 166147: 62 DEVICE LOTS, 19 SKIN GRAFTS, 2 BONE GRAFTS, 9 SOFT TISSUE GRAFTS. EIGHTY-ONE (81) TOTAL LOTS WERE DISTRIBUTED: 58 DEVICE LOTS WERE DISTRIBUTED, 4 USED AS QC SAMPLES; ALL 19 SKIN LOTS WERE DISTRIBUTED; ALL 2 BONE LOTS WERE DISTRIBUTED; 2 SOFT TISSUE LOTS WERE DISTRIBUTED, AND 7 WERE QUARANTINED. TWO LOTS OF TISSUE BASED DEVICE WERE IMPLANTED INTO THE PATIENT ASSOCIATED WITH THIS ADVERSE EVENT (B)(4). ALLOSOURCE HAS RECEIVED NO ADDITIONAL REPORTS OF ADVERSE REACTIONS OR ADVERSE EVENTS ASSOCIATED WITH THE OTHER 79 DISTRIBUTED LOTS. NINETY-ONE (91) TOTAL TISSUE LOTS WERE PRODUCED FROM DONOR 165433: 54 DEVICE LOTS, 28 SKIN GRAFTS, 9 SOFT TISSUE GRAFTS. SEVENTY-SEVEN (77) TOTAL LOTS WERE DISTRIBUTED: 48 DEVICE LOTS, 4 USED AS QC SAMPLES, 2 DISCARDED PRIOR TO DISTRIBUTION; 26 SKIN LOTS WERE DISTRIBUTED, AND 2 WERE QUARANTINED; 3 SOFT TISSUE LOTS WERE DISTRIBUTED, AND 6 WERE QUARANTINED. ONE LOT OF TISSUE BASED DEVICE WAS IMPLANTED INTO THE PATIENT ASSOCIATED WITH THIS ADVERSE EVENT (B)(4). ALLOSOURCE HAS RECEIVED NO ADDITIONAL REPORTS OF ADVERSE REACTIONS OR ADVERSE EVENTS ASSOCIATED WITH THE OTHER 76 DISTRIBUTED LOTS.

D

Patient 1

THREE LOTS OF XEMPLIFI DBM PLUS PUTTY 10 CC, FROM TWO DONORS, MANUFACTURED BY ALLOSOURCE WERE IMPLANTED INTO A PATIENT ON (B)(6) 2017. ON 8/17/2017 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)(6) 2017. THE THREE LOTS OF TISSUE BASED MEDICAL DEVICES REMAIN IN THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SURGEON TO DATE. THREE SEPARATE ADVERSE EVENT REPORTS ARE BEING SUBMITTED FOR THE EVENT ASSOCIATED WITH THIS PATIENT: 3000215346-2017-00006, 3000215346-2017-00007.