FDA.reportPublic FDA data

MAUDE MDR 4745567

MDR report key
4745567
Report number
1030489-2015-00899
Event key
0
Event type
3
Date of event
2013-09-09
Date received
2015-05-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
HUZEFA MAMOOLA
Address
1800 PYRAMID PLACE MEMPHIS TN 38132 US
Phone
901-901-9013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INFUSE BONE GRAFTFILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOINMEDTRONIC SOFAMOR DANEK USA, INCMPWNAUNKUNKN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-0401. R

Event Narratives#

D

Patient 1

IT WAS REPORTED IN A PUBLICATION THAT A RETROSPECTIVE REVIEW OF PATIENTS WITH FRACTURE NON-UNIONS INCLUDED IN TWO PROSPECTIVE DATABASES WAS PERFORMED AT TWO US LEVEL 1 TRAUMA CENTERS FROM (B)(6) 1998 (CENTER 1) OR (B)(6) 2004 (CENTER 2), RESPECTIVELY, UNTIL (B)(6) 2010. A TOTAL OF 182 PATIENTS (102 MALES AND 80 FEMALES) MET THE INCLUSION CRITERIA. THE MEAN AGE WAS 44 ? 13.6 YEARS. SIXTY-EIGHT PATIENTS WERE CONFIRMED SMOKERS, AND 30 PATIENTS HAD A HISTORY OF SMOKING AND REPORTED CESSATION PRIOR TO NONUNION SURGERY. THE REMAINING 84 PATIENTS REPORTED TO HAVE NEVER SMOKED. PATIENTS WERE STRATIFIED INTO THE FOLLOWING COHORTS FOR ANALYSIS, BASED ON THE BONE GRAFTING MODALITY: (1) AUTOGRAFT (N = 105), (2) ALLOGRAFT (N = 38), (3) ALLOGRAFT IN COMBINATION WITH AUTOGRAFT (N = 16), AND (4) RHBMP-2 WITH OR WITHOUT ADJUNCTIVEBONE GRAFTING SUBSTITUTE (N = 23). THE RHBMP-2 PRODUCT WAS MIXED WITH STERILE SALINE AND PREPARED IMMEDIATELY PRIOR TO USE FROM A KIT CONTAINING ALL NECESSARY COMPONENTS, ACCORDING TO THE MANUFACTURER?S INSTRUCTIONS. IN 6 PATIENTS, RHBMP-2 WAS ADMINISTERED WITHOUT BONE GRAFTING ADJUNCT, WHILE IN THE REMAINING 17 PATIENTS RHBMP-2 WAS COMBINED WITH ALLOGRAFT. THE BMP2 CASES CONSISTED OF 11 TIBIA, 5 FEMUR, AND 7 HUMERUS SURGERIES. ALL PATIENTS WERE FOLLOWED POSTOPERATIVELY FOR A MINIMUM OF 12 MONTHS, OR UNTIL CLINICAL AND RADIOGRAPHIC BONE HEALING OCCURRED. IN THE BMP2 COHORT, 4 PATIENTS HAD NEW ONSET POST-OP INFECTION. ALL 4 INFECTIONS WERE CLASSIFIED AS DEEP INFECTIONS.

N

Patient 1

ARTICLE CITATION: FLIERL ET AL. OUTCOMES AND COMPLICATION RATES OF DIFFERENT BONE GRAFTING MODALITIES IN LONG BONE FRACTURE NONUNIONS: A RETROSPECTIVE COHORT STUDY IN 182 PATIENTS. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH 2013, 8:33. MEAN AGE 52 YRS (+/- 15). 7 MALES, 16 FEMALES. IMPLANT DATE: BETWEEN (B)(6) 1998 AND (B)(6) 2010. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

N

Patient 1

(B)(4)