FUTURA CSI SUBTALAR IMPLANT DIAMETER 11 CSI-11

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 2017-12-04 for FUTURA CSI SUBTALAR IMPLANT DIAMETER 11 CSI-11 manufactured by Tornier Inc..

Event Text Entries

[93586795]
Patient Sequence No: 1, Text Type: N, H10


[93586796] It was reported that the screw became loose at 3 days post-op.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004983210-2017-00029
MDR Report Key7078602
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-12-04
Date of Report2017-07-27
Date of Event2017-06-25
Date Mfgr Received2017-07-27
Date Added to Maude2017-12-04
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 FDA3
Event Location3
Manufacturer ContactMR. DUSTIN SMITH
Manufacturer Street10801 NESBIT 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 NameFUTURA CSI SUBTALAR IMPLANT DIAMETER 11
Generic NameSUBTALAR PEG IMPLANT
Product CodeMJW
Date Received2017-12-04
Catalog NumberCSI-11
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORNIER INC.
Manufacturer Address10801 NESBIT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-12-04

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