inforMED
MalfunctionHWL

KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM

Received Oct 7, 2005

Report 9615741-2005-00035 · MDR key 698315

Device

Generic name

Kalix System

Manufacturer

Newdeal S.a.

Model number

*

Catalog number

140011

Lot number

DOUC

Product problems

  • Migration or Expulsion of Device
  • Replace

Patient

*

  • Surgery, prolonged
  • Surgical procedure aborted/stopped
  • Surgical procedure, additional

Narrative

Description of Event or Problem

THE IMPLANT WHEN SEATED IN THE SINUS AND EXPANDED WOULD POP OUT WHEN THE FOOT WAS PUT THROUGH RANGE OF MOTION. 3 KILIX IMPLANTS WERE PUT IN PLACE FOR THE SAME PT, BUT HAD THE SAME PROBLEM. IT WAS STARTED 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 LENTHENED 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, ANO SURGERY OCCURRED. THE SURGEON USED TRIAL IMPLANT TO DETERMINE THE SIZE OF THE FINAL ENDO PROSTHESIS. THIS MDR IS LINKED TO 9615741-2005-00036 AND 9615741-2005-00037.