FDA.reportPublic FDA data

MAUDE MDR 6472532

MDR report key
6472532
Report number
3002924436-2017-00006
Event key
0
Event type
3
Date of event
2016-08-29
Date received
2017-04-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CHARITY EMMONS
Address
11621 RESEARCH CIRCLE ALACHUA FL 32615 US
Phone
386-386-3864
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COPIOS PERICARDIUM MEMBRANEPERICARDIUM MEMBRANE, PRODUCT CODE: NPLTUTOGEN MEDICAL GMBHNPLNZ15160082N *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-0701. O

Event Narratives#

N

Patient 1

METHOD: RTI/TMI CONDUCTED A RE-REVIEW OF THE PRODUCT HISTORY FOR COPIOS PERICARDIUM MEMBRANES, PACKAGING PRODUCTION RECORDS, ENVIRONMENTAL MONITORING, DISTRIBUTION FOR RELATED COMPLAINTS ASSOCIATED TO THE LOT. RESULTS: PENDING ADDITIONAL INFORMATION CONCLUSION: PENDING ADDITIONAL INFORMATION FOLLOW-UP TO BE SUBMITTED. EXPLANTED NOT AVAILABLE.

D

Patient 1

IT WAS REPORTED THAT ON (B)(6) 2015 THE DENTIST UTILIZED COPIOS CANCELLOUS XENOGRAFT PARTICLES AND COPIOS PERICARDIUM MEMBRANE FOR TREATMENT OF TEETH 15,16 AND 17. ON (B)(6) 2016 THE PATIENT PRESENTED WITH EDEMA, INFECTION, PAIN AND SUPPURATION AND DEHISCENCE AND BONE LOSS. ON (B)(6) 2016 THE GRAFT WAS REMOVED.

N

Patient 1

METHOD: RTI/TMI CONDUCTED A RE-REVIEW OF THE PRODUCT HISTORY FOR COPIOS PERICARDIUM MEMBRANES, PACKAGING PRODUCTION RECORDS, ENVIRONMENTAL MONITORING, DISTRIBUTION FOR RELATED COMPLAINTS ASSOCIATED TO THE LOT. RESULTS: NO DEPARTURES FROM RTI/TMI PROCEDURES WERE NOTED DURING THE MANUFACTURING RECORDS RE-REVIEW THAT NEGATIVELY IMPACTED COPIOS PERICARDIUM MEMBRANES FROM LOT NZ15160082. RTI/TMI HAS DISTRIBUTED A TOTAL OF 98 GRAFTS SPECIFIC TO COPIOS PERICARDIUM MEMBRANES WITHOUT RELATED COMPLAINTS FOR THE LOT. CONCLUSION: GIVEN THE FACTS, THE XENOGRAFT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; TUTOPLAST?, WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER FINAL PACKAGING; SERIAL ID (B)(4) MET RTI/TMI'S SPECIFICATIONS AND RELEASE CRITERIA PRIOR TO DISTRIBUTION; THE SYMPTOMS EXPERIENCED BY THE PATIENT ARE EXPECTED FOR THIS KIND OF SURGERY, IT IS MORE PLAUSIBLE THE PATIENT'S SYMPTOMS WERE ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT.