SIGMA HP UNI FB KEEL OSTEOTOME 202447111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-13 for SIGMA HP UNI FB KEEL OSTEOTOME 202447111 manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

Report Number1818910-2019-115937
MDR Report Key9316626
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-13
Date of Report2019-10-18
Date of Event2019-10-18
Date Mfgr Received2019-10-18
Device Manufacturer Date2008-08-15
Date Added to Maude2019-11-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIGMA HP UNI FB KEEL OSTEOTOME
Generic NameKNEE INSTRUMENT : CUTTING INSTRUMENTS
Product CodeHWM
Date Received2019-11-13
Returned To Mfg2019-10-23
Catalog Number202447111
Lot NumberGM0808
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-13

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