FDA.reportPublic FDA data

MAUDE MDR 9383947

MDR report key
9383947
Report number
1818910-2019-118394
Event key
0
Event type
3
Date of event
2019-01-01
Date received
2019-11-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANTEVERSION OSTEOTOME SMHIP INSTRUMENTS : CUTTING INSTRUMENTSDEPUY ORTHOPAEDICS INC USHWM200231000SO2019587R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-270

Event Narratives#

No narrative records found.