FDA.reportPublic FDA data

MAUDE MDR 9349843

MDR report key
9349843
Report number
0001811755-2019-03801
Event key
0
Event type
3
Date of event
2019-10-25
Date received
2019-11-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. UNA BARRY
Address
INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK CARRIGTWOHILL NA
Phone
214-214-2145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZYPHR PERFORATOR BITDRILLS, BURRS, TREPHINES & ACCESSORIESSTRYKER INSTRUMENTS-KALAMAZOOHBF510006000119191017N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2001. R

Event Narratives#

No narrative records found.