MalfunctionHWL
KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 10MM
Received Apr 20, 2005 · Event occurred Oct 7, 2004
Report 9615741-2005-00004 · MDR key 593662
Device
Generic name
Kalix Implant System
Manufacturer
Newdeal S.a.Model number
*Catalog number
140010
Lot number
B085
Product problems
- Break
- Explanted
Patient
*
- Surgical procedure
Narrative
Description of Event or Problem
PT ORIGINALLY HAD THE DEVICE IMPLANTED IN 2003. IT WAS ALLEGED THAT THE DEVICE BROKE. A REVISION OPERATION WAS PERFORMED DUE TO THE BREAKAGE.