MalfunctionISH
KALIX FLAT FOOT IMPLANT EXTERNAL DIAM.9MM
Received Mar 31, 2005
Report 9615741-2005-00001 · MDR key 587605
Device
Generic name
Kalix Flat Fool Implant System
Manufacturer
Newdeal S.a.Model number
*Catalog number
140009
Lot number
B093
Product problems
- Break
- Replace
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DISTRIBUTOR REPORTED THAT UPON INSERTING IMPLANT TO THE PATIENT, THE DEVICE BROKE INTO TWO PIECES TO THE SCREW AND THE DEVICE BODY FELL AND BROKE ON THE OPERATION ROOM FLOOR. ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE W3AS NO SURGICAL DELAY NOR PATIENT INJURY REPORTED.