MESH 17X22MM OVAL 50MM HEIGHT

Additional Manufacturer Narrative

(B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. SAMPLE NOT RETURNED FOR EVALUATION.

Description of Event or Problem

THIS COMPLAINT IS THE UPDATE OF (B)(4). THE INDEX SURGERY WAS PERFORMED ON (B)(6) 2010 TO REMOVE A MALIGNANT STRUMA OVARII AND METASTATIC SPINAL TUMOR AT THE L3, AND THE REPORTED SURGICAL TITANIUM MESH AND AN EXPEDIUM-DI SYSTEM WERE IMPLANTED TO THE L1-L5. ON (B)(6) 2014, IT WAS CONFIRMED THAT THE MESH HAD STARTED TO GET KINKED. ALTHOUGH THE SURGEON DECIDED TO OBSERVE THE CONDITION AT THIS POINT, ON (B)(6) 2014, A BREAKING SOUND WAS HEARD FROM THE BODY. THE PATIENT WAS FOLLOWED-UP ON (B)(6) 2014, AND IT WAS CONFIRMED THAT THE LEFT ROD WAS BROKEN AND THE TITANIUM MESH WAS KINKED IN ANTERIOR DIRECTION. THE REVISION WAS PERFORMED ON (B)(6) 2014. THE EXPEDIUM WAS REMOVED, AND A SOLERA (MEDTRONIC) WAS IMPLANTED TO TH12-S1. THE X-RAY PHOTO TAKEN AFTER THE REVISION SEEMED TO INDICATE THAT THE KINK OF THE MESH WAS FIXED. HOWEVER, ANOTHER BREAKING SOUND WAS HEARD FROM THE BODY ON (B)(6) 2016, AND ON (B)(6) 2016 IT WAS CONFIRMED THAT THE LEFT ROD WAS BROKEN AND THE TITANIUM MESH WAS KINKED AGAIN. ANOTHER REVISION IS SCHEDULED ON (B)(6) 2016, AND THE MESH WITH WILL BE REPLACED WITH A SYNCAGE-EX SYSTEM.