FDA.reportPublic FDA data

MAUDE MDR 9426368

MDR report key
9426368
Report number
3006946279-2019-00536
Event key
0
Event type
3
Date of event
2019-11-27
Date received
2019-12-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REFOBACIN BONE CEMENT R 1X40GBONE CEMENT, ANTIBIOTICBIOMET FRANCE S.A.R.L.MBB3003940001A801AD2502R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-060

Event Narratives#

No narrative records found.