LOQTEQ® DIST. LATERAL FEMUR PLATE 4.5

Description of Event or Problem

DURING RECONSTRUCTIVE SURGERY ON THE DISTAL FEMUR AND PROXIMAL TIBIA, AN OSTEOTOMY WAS PERFORMED ON THE FEMUR. APPROXIMATELY FOUR MONTHS AFTER THE PROCEDURE, A RADIOLOGIC FOLLOW-UP REVEALED A FAILURE OF THE INTERNAL FIXATION.

Additional Manufacturer Narrative

DESPITE REPEATED REQUESTS, NO FURTHER INFORMATION ON THE CASE WAS PROVIDED. BASED ON THE LIMITED INFORMATION AVAILABLE, IT WAS NOT POSSIBLE TO ADEQUATELY ANALYZE THE CAUSES. THE INSPECTION OF THE DHR DID NOT REVEAL ANY DEVIATIONS FROM THE SPECIFICATION. THE SCREWS MAY NOT HAVE BEEN FULLY INSERTED INTO THE PANEL AT THE CORRECT ANGLE WITHOUT USING THE DRILL SLEEVE. THIS PREVENTS THE LOCKING OF THE LOCKING SCREWS. ANOTHER POSSIBLE CAUSE IS THAT THE SCREWS WERE NOT SUFFICIENTLY TIGHTENED AND THEREFORE COULD NOT LOCK ADEQUATELY IN THE PLATE. THE IMPLANTS WERE NOT AVAILABLE FOR EXAMINATION. THE CASES HAD ALREADY OCCURRED SEVERAL MONTHS PREVIOUSLY AT THE TIME OF REPORTING.