LATITUDE ULNAR CAP MEDIUM DKY068 4751AO019

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-16 for LATITUDE ULNAR CAP MEDIUM DKY068 4751AO019 manufactured by Tornier, Inc..

Event Text Entries

[5760817] The hospital (b)(6) reported to tornier that the implant was explanted from the same pt due to aseptic loosening.
Patient Sequence No: 1, Text Type: D, B5


[13082386] This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004983210-2015-00005
MDR Report Key4616122
Report Source06
Date Received2015-03-16
Date Added to Maude2015-05-04
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 FDA0
Event Location0
Manufacturer ContactKEVIN SMITH
Manufacturer Street10801 NESBITT AVE SOUTH
Manufacturer CityBLOOMINGTON MN 55437
Manufacturer CountryUS
Manufacturer Postal55437
Manufacturer Phone9529217121
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLATITUDE ULNAR CAP MEDIUM
Generic NameNONE
Product CodeKWH
Date Received2015-03-16
Model NumberDKY068
Catalog Number4751AO019
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTORNIER, INC.
Manufacturer AddressBLOOMINGTON MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.