XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD A PROCEDURE ON (B)(6) 2016 FOR ADOLESCENT SCOLIOSIS CORRECTION. SURGERY WENT WELL, CORRECTION OBTAINED WITH NO COMPLICATION. SCREWS PLACED T3-L3. PATIENT WAS BROUGHT BACK FOR SURGERY (B)(6) 2018 DUE TO L3 LEFT SIDED SCREW BACKED OUT AND POTENTIAL CAUSE OF PAIN. SURGEON DECIDED TO REMOVE ALL INSTRUMENTATION AS THE SPINE HAS FUSED AND INSTRUMENTATION NO LONGER NEEDED. ON REMOVING THE SCREWS, ONE OF THE SCREWS WAS FOUND BROKEN. THIS CAUSED NO ISSUE TO THE PATIENT AND WASN'T THE REASON FOR THE REVISION SURGERY. THE PATIENT HAD A TOTAL OF 21 SCREWS IN ORIGINALLY. ONE SCREW HAD BACKED OUT AND ONE SCREW WAS BROKEN.

Additional Manufacturer Narrative

THE EVENT WAS CONFIRMED BASED ON THE COMMUNICATION WITH THE SALES REPRESENTATIVE. X RAYS WERE PROVIDED FOR EVALUATION. THE SCREW WAS LOST AT THE HOSPITAL DURING STERILIZATION AND IS UNAVAILABLE FOR EVALUATION. MANUFACTURING HISTORY WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS AFTER THE INITIAL SURGERY DUE TO LEFT SCREW BACKING OUT POTENTIALLY CAUSING PAIN. THE PATIENT HAD GOOD BONE QUALITY, NO CO-MORBIDITIES, NONSMOKER, ADOLESCENT IDIOPATHIC SCOLIOSIS CONDITION, NORMAL POST OP ACTIVITY LEVEL AND DID NOT SUFFER A FALL. IT WAS REPORTED THAT THE PATIENT FUSED AND THE INSTRUMENTATION WAS NO LONGER NEEDED. IT IS STATED IN THE IFU THAT "THESE IMPLANTS ARE TEMPORARY INTERNAL FIXATION DEVICES DESIGNED TO STABILIZE THE OPERATIVE SITE DURING THE NORMAL HEALING PROCESS. AFTER HEALING OCCURS, THESE DEVICES SERVE NO FUNCTIONAL PURPOSE AND CAN BE REMOVED." THE DEVICE WAS IMPLANTED FOR A PERIOD OF ALMOST 2 YEARS. THE MOST LIKELY ROOT CAUSE IS DEVICE WAS USED PAST ITS FUNCTIONAL PURPOSE, WITH EXCESSIVE FORCE PLACED BY THE SURGEON AND NON TAPPING POSSIBLY CONTRIBUTING TO THE EVENT.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD A PROCEDURE ON (B)(6) 2016 FOR ADOLESCENT SCOLIOSIS CORRECTION. SURGERY WENT WELL, CORRECTION OBTAINED WITH NO COMPLICATION. SCREWS PLACED T3-L3. PATIENT WAS BROUGHT BACK FOR SURGERY (B)(6) 2018 DUE TO L3 LEFT SIDED SCREW BACKED OUT AND POTENTIAL CAUSE OF PAIN. SURGEON DECIDED TO REMOVE ALL INSTRUMENTATION AS THE SPINE HAS FUSED AND INSTRUMENTATION NO LONGER NEEDED. ON REMOVING THE SCREWS, ONE OF THE SCREWS WAS FOUND BROKEN. THIS CAUSED NO ISSUE TO THE PATIENT AND WASN'T THE REASON FOR THE REVISION SURGERY. THE PATIENT HAD A TOTAL OF 21 SCREWS IN ORIGINALLY. ONE SCREW HAD BACKED OUT AND ONE SCREW WAS BROKEN.