FDA.reportPublic FDA data

MAUDE MDR 8684748

MDR report key
8684748
Report number
0008010177-2019-00032
Event key
0
Event type
3
Date of event
2019-05-14
Date received
2019-06-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. RYLEE KOOLE
Address
BOETZINGERSTR. 41 FREIBURG D-791
Phone
761-761-7614
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIRECTINJECT ON DEMAND HA CEMENTIMPLANTSTRYKER ORTHOPAEDICS-LIMERICKGXP79-45910UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-1001. O

Event Narratives#

No narrative records found.