MalfunctionHSH
ITOTAL
Received Aug 3, 2012 · Event occurred Jul 3, 2012
Report 3004153240-2012-00063 · MDR key 2702301
Device
Product problems
- Break
Patient
74 YR
- No Information
Narrative
Description of Event or Problem
THE LOCKING MECHANISM ON THE LATERAL B INSERT WAS DAMAGED DURING SURGERY. THE LATERAL A INSERT WAS IMPLANTED. THE LATERAL B POLY IS 1MM THICKER THAN THE LATERAL A POLY.
Additional Manufacturer Narrative
THE LOCKING MECHANISM ON THE LATERAL B INSERT WAS DAMAGED DURING SURGERY. THE LATERAL A INSERT WAS IMPLANTED. THE LATERAL B POLY IS 1MM THICKER THAN THE LATERAL A POLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.