9560524

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 2019-11-29 for 9560524 manufactured by Medtronic Sofamor Danek Usa, Inc.

MAUDE Entry Details

Report Number1030489-2019-01356
MDR Report Key9391768
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-10-31
Date Mfgr Received2019-10-31
Device Manufacturer Date2018-08-22
Date Added to Maude2019-11-29
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 ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Street4340 SWINEA RD
Manufacturer CityMEMPHIS TN 38118
Manufacturer CountryUS
Manufacturer Postal Code38118
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Product CodeLXH
Date Received2019-11-29
Model NumberNA
Catalog Number9560524
Lot NumberMY18H001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Address4340 SWINEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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