FDA.reportPublic FDA data

MAUDE MDR 9908586

MDR report key
9908586
Report number
3007700286-2020-00033
Event key
0
Event type
3
Date of event
2020-03-16
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
W. RECKLING, M.D.
Address
471 EL CAMINO REAL SUITE 101 SANTA CLARA, CA US
Phone
207-207-2070
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IFUSE IMPLANT SYSTEMORTHOPEDIC RODSI-BONE, INC.OUR7050M-902692121R N

Patients#

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

Event Narratives#

No narrative records found.