FDA.reportPublic FDA data

MAUDE MDR 698315

MDR report key
698315
Report number
9615741-2005-00035
Event key
0
Event type
3
Date received
2005-10-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
YANPING WANG
Address
311C ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 11MMKALIX SYSTEMNEWDEAL S.A.HWL*140011DOUCNRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-10-070

Event Narratives#

D

Patient 1

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.