FDA.reportPublic FDA data

MAUDE MDR 9908201

MDR report key
9908201
Report number
0009610622-2020-00137
Event key
0
Event type
3
Date of event
2020-03-05
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. KEVIN SMITH
Address
325 CORPORATE DRIVE MAHWAH NJ 07430 US
Phone
201-201-2018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TROCHANTERIC NAIL KIT, STST GAMMA3? ?11X180MM X 130?ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIESSTRYKER TRAUMA KIELHSB41301180SKU115031N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. O

Event Narratives#

No narrative records found.