IFUSE IMPLANT SYSTEM 7050M-90

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for IFUSE IMPLANT SYSTEM 7050M-90 manufactured by Si-bone, Inc..

MAUDE Entry Details

Report Number3007700286-2020-00033
MDR Report Key9908586
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-16
Date Mfgr Received2020-03-16
Device Manufacturer Date2019-09-09
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactW. RECKLING, M.D.
Manufacturer Street471 EL CAMINO REAL SUITE 101
Manufacturer CitySANTA CLARA, CA
Manufacturer CountryUS
Manufacturer Phone2070700
Manufacturer G1SI-BONE, INC.
Manufacturer Street471 EL CAMINO REAL SUITE 101
Manufacturer CitySANTA CLARA, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIFUSE IMPLANT SYSTEM
Generic NameORTHOPEDIC ROD
Product CodeOUR
Date Received2020-03-31
Model Number7050M-90
Lot Number2692121
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSI-BONE, INC.
Manufacturer Address471 EL CAMINO REAL SUITE 101 SANTA CLARA, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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