FDA.reportPublic FDA data

MAUDE MDR 3687562

MDR report key
3687562
Report number
2090010-2014-00007
Event key
0
Event type
3
Date received
2014-03-12
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
VIVIAN NELSON
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
1OPTIPLUG - UNK SIZEOPTIPLUGISOTIS ORTHOBIOLOGICS, INCMBPXXX-OPTIPLUGR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-120

Event Narratives#

D

Patient 1

"A RECENT COMPLAINT CONCERNING SYNPLUG AND OSTEOLYSIS RESULTED IN A HEALTH HAZARD EVAL. THIS EVAL IDENTIFIED OSTEOLYSIS AS MEETING THE CRITERIA OF MDR REPORTABLE. A RETROSPECTIVE REVIEW HAS BEEN CONDUCTED OF OUR COMPLAINT MANAGEMENT SYSTEM RESULTING IN THE FILING OF THIS MDR".

N

Patient 1

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.