MalfunctionHSH
ITOTAL
Received Aug 28, 2012 · Event occurred Jul 1, 2012
Report 3004153240-2012-00069 · MDR key 2729500
Device
Product problems
- Break
Patient
74 YR
- No Information
Narrative
Description of Event or Problem
THE TAB THAT IS PART OF THE LOCKING MECHANISM ON THE LATERAL POLY INSERT WAS DAMAGED DURING INSERTION. THE B LATERAL POLY INSERT WAS IMPLANTED. THE B LATERAL INSERT IS 1 MM THICKER THAN THE A LATERAL INSERT.
Additional Manufacturer Narrative
THE LAB THAT IS PART OF THE LOCKING MECHANISM ON THE A LATERAL POLY INSERT WAS DAMAGED DURING INSERTION. THE B LATERAL INSERT WAS IMPLANTED. THE B LATERAL INSERT IS 1 MM THICKER THAN THE A LATERAL INSERT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.
Remedial action
- Notification