EVOLVE STEM 496-S095

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-12-20 for EVOLVE STEM 496-S095 manufactured by Wright Medical Technology, Inc..

MAUDE Entry Details

Report Number1043534-2000-00123
MDR Report Key310684
Report Source05,06
Date Received2000-12-20
Date of Event2000-11-15
Date Mfgr Received2000-11-28
Device Manufacturer Date2000-04-01
Date Added to Maude2001-01-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Manufacturer ContactDEBBY DAURER
Manufacturer Street5677 AIRLINE RD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal38002
Manufacturer Phone9018674601
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameEVOLVE STEM
Generic NameSMALL JOINT COMPONENT
Product CodeKIG
Date Received2000-12-20
Returned To Mfg2000-12-05
Model NumberNA
Catalog Number496-S095
Lot Number040A099818
ID NumberNA
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagY
Date RemovedB
Device Sequence No1
Device Event Key300546
ManufacturerWRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Address5677 AIRLINE RD ARLINGTON TN 38002 US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-12-20

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