FDA.reportPublic FDA data

MAUDE MDR 9690263

MDR report key
9690263
Report number
3006460162-2019-00094
Event key
0
Event type
3
Date of event
2019-06-14
Date received
2020-02-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. KRISS ANDERSON
Address
2850 FRONTIER DR WARSAW, IN US
Phone
268-268-2686
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RESPONSE BANDLOC SPINAL FIXATIONBONE FIXATION CERCLAGE, SUBLAMINARORTHOPEDIATRICS, CORPOWI10-1102-1555181675R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-100

Event Narratives#

No narrative records found.