INTERNATIONAL AFFILIATE RECEIVED ADVERSE INCIDENT REPORT FROM MHRA REPORTING THAT A SABER CAGE WAS MOUNTED ON INSERTER AND PLACED IN SPINAL SPACE. WHEN USING A MALLET TO PUSH THE CAGE INTO THE SPACE, THE CAGE SPLINTERED INTO SEVEN PIECES. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NONE. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER): ALL PIECES REMOVED AND PLACED TOGETHER TO CHECK ALL ACCOUNTED FOR. ANOTHER CAGE WAS THEN INSERTED INTO THE SPINAL SPACE WITHOUT INCIDENT.
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Patient 1
ADDITIONAL NARRATIVE: A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
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Patient 1
THE 2G EEDGE I/F CAGE, 11X10X25 WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE CAGE HAD FRACTURED INTO 7 SEGMENTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A TWELVE MONTH COMPLAINT TREND ANALYSIS WAS CONDUCTED AND THE DEVICE FAMILY HAS BEEN REVIEWED AS A PART OF POST MARKET SURVEILLANCE ACTIVITIES WITH NO DESIGN ACTIONS REQUIRED AS A RESULT. THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE ACCOMPANYING INSTRUCTIONS FOR USE (IFU) INDICATE THAT EXCESSIVE TORQUE ON THE IMPLANT CAN CAUSE SPLITTING OR FRACTURE. ADDITIONALLY, THE CAGE SHOULD BE FULLY SEATED AGAINST THE INSERTER OR IMPACTION FORCES COULD BE APPLIED TO A SMALL SURFACE OF THE IMPLANT CAUSING FRACTURE. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS THERE HAVE BEEN NO ISSUES IDENTIFIED IN THE RELEASE OF THIS IMPLANT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.