A patient was undergoing a surgery on (b)(6) 2021 performed by doctor (b)(6) to place eleos components due to resection of a patient's tumor.While attempting final insertion of the axial pin, a small piece of the poly locking ring sheared off.The axial pin was explanted, and a new axial pin as obtained.When attempting final insertion of the new axial pin, the same issue occurred and a small piece of the poly locking ring was sheered off.The surgeon decided to keep this pin inserted in the patient.The issue led to a small delay in surgery which lasted less than 40 minutes.The regional sales manager that was present for the case stated that he did not believe that the surgeon's technique for inserting the axial pin was at fault for the failure.
|