ITOTAL

Additional Manufacturer Narrative

THE LATERAL A POLY WOULD NOT LOCK INTO THE TRAY. THE LATERAL B POLY WAS USED TO COMPLETE THE CASE. 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. DEVICE EVAL: THE LATERAL A POLY WAS RETURNED TO CONFORMIS FOR EVAL. VISUAL EXAMINATION OF THE RETURNED LATERAL A POLY SHOWED THE SNAP FEATURE WAS DAMAGED. IT APPEARS THAT THE SNAP WAS DAMAGED AS A RESULT OF THE INSERT NOT BEING PROPERLY ALIGNED AT THE TIME OF IMPACTION. WITH THE INSERT DAMAGED IN THIS MANNER, IT IS LIKELY THAT THE INSERT WAS NOT COMPLETELY LOCKED INTO THE TRAY.

Description of Event or Problem

THE LATERAL A POLY WOULD NOT LOCK INTO THE TRAY. THE LATERAL B POLY WAS USED TO COMPLETE THE CASE. THE LATER B POLY IS 1MM THICKER THAN THE LATERAL A POLY.