FDA.reportPublic FDA data

MAUDE MDR 3459089

MDR report key
3459089
Report number
2090010-2013-00014
Event key
0
Event type
3
Date received
2013-10-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CAREN FINKELSTEIN
Address
315 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DBP PUTTY 1CCNAISO TISNUN10-220-1030UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-0801. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THE CLINICIAN REOPENED A SITE GRAFTED WITH DYNABLAST PUTTY PLACED AT MOLAR # 19, AND FOUND THAT THERE WAS NO SOLID BONE. THE GRAFT WAS REMOVED AND THE SITE WAS RE-GRAFTED AND THE PT WAS SENT HOME FOR A COUPLE OF MONTHS TO REEVALUATE FOR BONE TO FILL THE SITE.

N

Patient 1

THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.