FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE 04.268.000S

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 2020-03-30 for FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE 04.268.000S manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2020-01581
MDR Report Key9896854
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2020-03-03
Date Mfgr Received2020-03-30
Date Added to Maude2020-03-30
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 ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1WERK GRENCHEN (CH)
Manufacturer StreetSOLOTHURNSTRASSE 186
Manufacturer CityGRENCHEN 2540
Manufacturer CountrySZ
Manufacturer Postal Code2540
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE
Generic NameAPPLIANCE,FIXATION,NAIL
Product CodeKTT
Date Received2020-03-30
Model Number04.268.000S
Catalog Number04.268.000S
Lot Number2L62443
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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