MalfunctionHWL
KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 13MM
Received Feb 10, 2006
Report 9615741-2006-00003 · MDR key 676012
Device
Product problems
- Peeled/Delaminated
- Replace
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
USER FACILITY REPORTED THAT THE PLASTIC COATING WAS PUSHING OVER METAL SEVERAL TIMES DURING A SURGERY IN 2005. THERE WAS ANOTHER DEVICE AVAILABLE TO COMPLETE THE SURGERY. NO PATIENT INJURY OR SURGERY DELAY WAS REPORTED.