CD HORIZON SPINAL SYSTEM UNK

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 CD HORIZON SPINAL SYSTEM UNK manufactured by Medtronic Sofamor Danek Usa, Inc..

MAUDE Entry Details

Report Number1030489-2019-01357
MDR Report Key9391870
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date Mfgr Received2019-11-26
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 Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal Code38132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCD HORIZON SPINAL SYSTEM
Generic NameAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
Product CodeKWP
Date Received2019-11-29
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC.
Manufacturer Address1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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