IDUO G2 M57230600210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-11 for IDUO G2 M57230600210 manufactured by Conformis, Inc..

MAUDE Entry Details

Report Number3004153240-2019-00278
MDR Report Key9306516
Date Received2019-11-11
Date of Report2019-11-11
Date of Event2019-10-01
Date Mfgr Received2019-10-23
Device Manufacturer Date2012-05-31
Date Added to Maude2019-11-11
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 ContactPAUL SMOLENSKI
Manufacturer Street600 TECHNOLOGY PARK DRIVE
Manufacturer CityBILLERICA MA 01821
Manufacturer CountryUS
Manufacturer Postal01821
Manufacturer Phone7813459093
Manufacturer G1CONFORMIS, INC.
Manufacturer Street600 RESEARCH DRIVE
Manufacturer CityWILMINGTON MA 01887
Manufacturer CountryUS
Manufacturer Postal Code01887
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIDUO G2
Generic NameBICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
Product CodeNPJ
Date Received2019-11-11
Catalog NumberM57230600210
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONFORMIS, INC.
Manufacturer Address600 TECHNOLOGY PARK DRIVE BILLERICA MA 01821 US 01821


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-11

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