TFNA FENESTRATED HELICAL BLADE 95MM 04.038.395

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 2020-03-27 for TFNA FENESTRATED HELICAL BLADE 95MM 04.038.395 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2020-01564
MDR Report Key9889010
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-27
Date of Report2020-02-28
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 G1ELMIRA
Manufacturer Street35 AIRPORT ROAD
Manufacturer CityHORSEHEADS NY 14845
Manufacturer CountryUS
Manufacturer Postal Code14845
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTFNA FENESTRATED HELICAL BLADE 95MM
Generic NameAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Product CodeKTT
Date Received2020-03-27
Model Number04.038.395
Catalog Number04.038.395
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-27

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