Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l5-s1, t9-t10, t12-l1, t8-s1, t8-t12 and sacrum thoraco-lumbar arthrodesis for an indication of neurological spine deformity.It was reported that there was malposition of left l4 screw and the additional surgery was performed on (b)(6) 2015 for removal of l4 screw and analgesics treatment.The screw was wrongly placed and failure of pedicle aiming by the operator.There were no patient symptoms reported.There were no further complications reported regarding the event.
|