SFX X20 TORQUE DRIVER SHAFT 289410300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for SFX X20 TORQUE DRIVER SHAFT 289410300 manufactured by Depuy Spine Inc.

MAUDE Entry Details

Report Number1526439-2020-00797
MDR Report Key9897691
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-03
Date of Event2020-03-02
Date Mfgr Received2020-03-03
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1BRIDGEWATER DISTRIBUTION
Manufacturer Street50 SCOTLAND BOULEVARD
Manufacturer CityBRIDGEWATER MA 02324
Manufacturer CountryUS
Manufacturer Postal Code02324
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSFX X20 TORQUE DRIVER SHAFT
Generic NameDRIVER, PROSTHESIS
Product CodeHWR
Date Received2020-03-30
Model Number289410300
Catalog Number289410300
Lot NumberNW237245
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SPINE INC
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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