3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM 212.114

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-20 for 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM 212.114 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2020-01398
MDR Report Key9859934
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-20
Date of Report2020-02-20
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-20
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 Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1SYNTHES MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM
Generic NameAPPLIANCE, FIXATION, NAIL
Product CodeKTT
Date Received2020-03-20
Model Number212.114
Catalog Number212.114
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 2020-03-20

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