CORTICAL STABILIZATION SCREW

Description of Event or Problem

BACKED OUT LOCKING SCREWS AT FLS PLATE H-SHAPE AFTER MORE THAN 4 YEARS AT DIABETIC PATIENT WITH SKIN LESION.

Additional Manufacturer Narrative

WE HAVE INSPECTED THE DHF OF THE AFFECTED PLATE AND SCREWS AND THE MATERIAL CERTIFICATE AND THE BATCH WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE ARTICLE MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PATIENT IS DIABETIC AND HAD A SKIN LESION WHICH THE SCREW WORKED OUT THROUGH. REMAINING 3 SCREWS WERE REMOVED DURING SURGERY. SURGEON REPORTED THAT 2 OF THE SCREWS THAT WERE REMOVED DID NOT APPEAR TO BE LOCKED INTO THE PLATE. THE WOUND WAS CLOSED AS FRACTURE WAS HEALED. AS NO X-RAYS OR FURTHER SURGERY DATA WAS PROVIDED, THE COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, I.T.S.GMBH OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THIS REPORT INCLUDES 1 PLATE AND 3 LOCKING SCREWS AND THEREFORE THIS IS REPORT 2/4.