LATITUDE ELBOW SYSTEM NOT REPORTED

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 2020-01-07 for LATITUDE ELBOW SYSTEM NOT REPORTED manufactured by Tornier Inc.

MAUDE Entry Details

Report Number3004983210-2019-00124
MDR Report Key9559732
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-07
Date of Report2020-01-07
Date Mfgr Received2019-12-18
Date Added to Maude2020-01-07
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 ContactMS. MARY MCNABB
Manufacturer Street4375 E PARK 30 DRIVE
Manufacturer CityCOLUMBIA CITY IN 46725
Manufacturer CountryUS
Manufacturer Postal46725
Manufacturer Phone5743713153
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLATITUDE ELBOW SYSTEM
Generic NameLATITUDE FLEXIBLE REAMER
Product CodeJDB
Date Received2020-01-07
Catalog NumberNOT REPORTED
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORNIER INC
Manufacturer Address10801 NESBITT AVENUE S BLOOMINGTON MN 55437 US 55437


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2020-01-07

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