ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM

Additional Manufacturer Narrative

INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: KEYENCE VHX-5000 DIGITAL MICROSCOPE. WE MADE A VISUAL INSPECTION OF THE PARTS. THE SCREW AS WELL AS THE PETALS SHOW SIGNIFICANT WEAR AND ABRADE. THE HEXAGON OF THE LOCKING PIN AS WELL AS THE HEXAGON IN THE SCREW ARE WITHOUT SIGNIFICANT DAMAGES OR HINTS OF MISUSE. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS OF THE PRESENT LOT HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE/PATIENT RELATED. RATIONAL: THE WEAR MARKS ON THE SCREWS ARE CLEAR HINTS FOR RELATIVE MOVEMENT BETWEEN SCREW AND PLATE. THIS CAN GO SO FAR THAT THE EDGE OF THE SLOT HOLE OF THE PLATE CAN ABRADE SINGLE PETALS. IF SINGLE PETALS SEIZE UP, IT CAN COME TO A BACKING OUT OF THE SCREW OR LOOSENING OF THE PETALS (TEARING AWAY). NO CAPA IS NECESSARY.

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

COUNTRY OF COMPLAINT: JAPAN. IT WAS REPORTED THAT FOUR MONTHS AFTER THE PRIMARY SURGERY ((B)(6) 2016) LOOSE SCREWS WAS DISCOVERED BY X-RAYS. ON ONE OF THE SCREWS THE PIN WAS LOOSE ALSO. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2017, DURING THE SURGERY IT WAS DISCOVERED THAT THE HEAD OF THE SCREW OF THE LOCK PIN THAT WAS LOOSE WAS BROKEN. THEREFORE, THE SCREW WAS NOT REMOVED. THE BROKEN FRAGMENTS COULD BE REMOVED BY SUCTION TUBE. THE PROCEDURE FOR A REPLACEMENT SCREW WAS PERFORMED WITHOUT ANY PROBLEMS.