FDA.reportPublic FDA data

MAUDE MDR 9391623

MDR report key
9391623
Report number
3003184527-2019-01556
Event key
0
Event type
3
Date of event
2019-10-30
Date received
2019-11-29
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
MRS. ASTRID WEBER
Address
NECKARSULMSTRASSE 28 GRENCHEN 2540 CH
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ELEMENT RC INICELL, PF 5.0, E 5.0, L12.5DENTAL IMPLANTTHOMMEN MEDICAL AGDZE4.23.14517386N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. O

Event Narratives#

No narrative records found.