TORNIER
Received Jan 8, 2010 · Event occurred Dec 17, 2009
Report 9610667-2010-00020 · MDR key 2627518
Device
Product problems
- Migration or Expulsion of Device
Patient
54 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT IS REPORTED THAT A PT WITH A TORNIER FOOT FIXATION SYSTEM ORIGINALLY IMPLANTED ON (B)(6) 2008 PRESENTED FOR EVALUATION OF A SCREW BACKING OUT OF POSITION, BUT WAS OTHERWISE ASYMPTOMATIC. IT IS REPORTED THAT ONE OF THE FIXATION SCREWS WAS CLINICALLY CONFIRMED AS BACKING OUT OF POSITION AND ALSO THAT THE FIXATION PLATE HAD BROKEN. THE FIXATION SYSTEM, PLATE AND ALL SCREWS, WAS COMPLETELY REMOVED BY REVISION SURGERY ON (B)(6) 2009, WITHOUT DEVICE REPLACEMENT REQUIRED. NO ADDITIONAL ADVERSE PT EFFECT, OTHER THAN THE REVISION SURGICAL EVENT TO ALLOW EXPLANTATION, IS REPORTED TO HAVE OCCURRED. DEVICE SERIAL/LOT NUMBERS HAVE NOT BEEN IDENTIFIED. DEVICE RETURN FOR EVALUATION HAS BEEN REQUESTED AND MAY OCCUR. (B)(4).