CLASSIC GREAT TOE IMPLANT SIZE 50 CGT-050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-31 for CLASSIC GREAT TOE IMPLANT SIZE 50 CGT-050 manufactured by Tornier Inc.

Event Text Entries

[3173705] Device implanted on (b)(6) 2011. Explanted on (b)(6) 2012. The implant was broken , had substantial pitting and had changed to an extreme yellow color. Device was replaced with another of the same type of implant.
Patient Sequence No: 1, Text Type: D, B5


[10579031] 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 Number3004983210-2013-00001
MDR Report Key2979984
Report Source05
Date Received2013-01-31
Date of Report2013-01-23
Date of Event2012-11-26
Date Mfgr Received2013-01-23
Device Manufacturer Date2009-05-01
Date Added to Maude2013-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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 Phone9524267643
Manufacturer G1TORNIER INC.
Manufacturer Street10801 NESBITT AVE SOUTH
Manufacturer CityBLOOMINGTON MN 55437
Manufacturer CountryUS
Manufacturer Postal Code55437
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLASSIC GREAT TOE IMPLANT SIZE 50
Generic NameNONE
Product CodeKWH
Date Received2013-01-31
Catalog NumberCGT-050
Lot Number120330709E
Device Expiration Date2014-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORNIER INC
Manufacturer AddressEDINA MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-01-31

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