I TOTAL
Received Aug 28, 2012 · Event occurred Jul 1, 2012
Report 3004153240-2012-00070 · MDR key 2729487
Device
Product problems
- Break
Patient
61 YR
- No Information
Narrative
Description of Event or Problem
THE TAB THAT IS PART OF THE LOCKING MECHANISM ON THE LATERAL A POLY INSERT WAS DAMAGED DURING SURGERY. THE LATERAL B POLY INSERT WAS IMPLANTED. THE LATERAL B INSERT IS 1 MM THICKER THAN THE LATERAL A INSERT.
Additional Manufacturer Narrative
THE TAB THAT IS PART OF THE LOCKING MECHANISM ON THE LATERAL A POLY INSERT WAS DAMAGED DURING SURGERY. THE LATERAL B POLY INSERT WAS IMPLANTED. THE LATERAL B INSERT IS 1 MM THICKER THAN THE LATERAL A INSERT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. DEVICE EVAL: THE A LATERAL INSERT WAS RETURNED FOR EVAL. EXAMINATION OF THE RETURNED A LATERAL INSERT CONFIRMS DAMAGE TO THE SNAP FEATURE OF THE LOCKING MECHANISM. EXAMINATION INDICATES THAT THE POLY INSERT MAY NOT HAVE BEEN ALIGNED PROPERLY AT THE TIME OF IMPACTION.
Remedial action
- Notification