VERTEBRAL BODY TETHERING SYSTEM THE TETHER

Description of Event or Problem

AN OVERCORRECTION WAS ORIGINALLY MEASURED AT 11 DEGREES DURING THE PARTICIPANT'S YEAR 3 VISIT ON (B)(6)2024 AND WAS MONITORED UNTIL THE NEXT VISIT. AT THE NEXT VISIT ON (B)(6) 2024 THE MISALIGNMENT WAS RE-EVALUATED AND CHANGED TO REFLECT THE OVERCORRECTION, NOW WORSENED TO 14 DEGREES. PLANNED REVISION SURGERY TO RELEASE TENSION FROM T11 TO L2 TO STOP OVERCORRECTION WAS PLANNED. FOLLOWING THESE FINDINGS, THE PARTICIPANT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2024 FOR A REVISION SURGERY TO REMOVE THE TETHER FROM T11 TO L2. THE PARTICIPANT WAS HOSPITALIZED OVERNIGHT UNTIL (B)(6) 2024 AND WILL RETURN TO CLINIC TO BE MONITORED. THIS EVENT WAS REPORTED TO THE MANUFACTURER VIA (B)(6) PER (B)(4).