KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 14MM * 140014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-10-07 for KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 14MM * 140014 manufactured by Newdeal S.a..

Event Text Entries

[440833] The implant when seated in the sinus and expanded would pop out when the foot wsa put through the range of motion. 3 kilix implants were put in place for the same pt, but had the same problem. It was stated that the surgeon operated with the proper technique. The pt received a debridment of the sinus tarsi. There was no pt injury reported. The surgery was lengthened about 30 minutes. The pt was not finally treated. No another kalix was put in place. The pt was deemed to be a poor candidate for another surgery and at this time no surgery occurred. The surgeon used trial implant to determine the size of final endo prosthesis. This mdr is linked to 9615741-2005-00035 and 9615741-2005-00036.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615741-2005-00037
MDR Report Key698558
Report Source08
Date Received2005-10-07
Date of Report2005-10-07
Date Mfgr Received2005-09-08
Date Added to Maude2006-04-13
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 Location0
Manufacturer ContactYANPING WANG
Manufacturer Street311C ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362322
Manufacturer G1NEWDEAL S.A.
Manufacturer Street10 PLACE D'HELVETIE
Manufacturer CityLYON 69006
Manufacturer CountryFR
Manufacturer Postal Code69006
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 14MM
Generic NameKALIX SYSTEM
Product CodeHWL
Date Received2005-10-07
Model Number*
Catalog Number140014
Lot NumberB0B4
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key687645
ManufacturerNEWDEAL S.A.
Manufacturer Address* LYON FR
Baseline Brand NameKALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 14MM
Baseline Generic NameKALIX SYSTEM
Baseline Model No*
Baseline Catalog No140014
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2005-10-07

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