KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM
Received Oct 7, 2005
Report 9615741-2005-00035 · MDR key 698315
Device
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.