Some adverse events or treatment failures may lead to additional surgical interventions. Relatedness of these subsequent spinal surgical interventions will be assessed Total events and total number of subjects who have additional surgeries will be summarized. The numbers of revisions (total, preventive and non-preventive), removals, reoperations and other surgeries will also be summarized.

A relatedness determination will be made by the investigator to the original study device and the original study surgery to a subsequent surgical intervention.

A device deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labeling.

Main Thoracic Cobb Angle will be calculated from the PA (posteroanterior) TL (thoracic/lumbar) spine radiograph. Main Thoracic Cobb Angle is reported in units of degrees. A positive angle indicates a curve where the apex is to the subject's right of the adjacent vertebra, i.e. the angle opens to the subject's left. A negative angle indicates a curve where the apex is to the subject's left of the adjacent vertebra, i.e., the angle opens to the subject's right.

Proximal Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Proximal Thoracic Cobb Angle is reported in units of degrees.

Thoracolumbar/Lumbar Cobb Angle will be calculated from the PA TL spine radiograph. Thoracolumbar/Lumbar Cobb Angle will be reported in units of degrees.

The Instrumented Cobb Angle will be calculated from the PA TL Spine radiograph. It will be measured by drawing lines through the superior endplate of the upper instrumented vertebra and the inferior endplate of lower instrumented vertebra. The Instrumented Cobb Angle upper and lower end vertebrae will be defined at PostOp and maintained for all follow-up measurements. Instrumented Cobb Angle will be reported in units of degrees.

Thoracic Kyphosis will be calculated from the Lateral TL Spine radiograph and will be measured as the angle between the superior endplate of T5 and the inferior endplate of T12. Thoracic Kyphosis is reported in units of degrees. Positive angle corresponds to kyphotic curvature, whereas negative angle corresponds to lordotic curvature.

Lumbar Lordosis will be calculated from the Lateral TL Spine radiograph and will be measured as the angle between the superior endplate of S1 and the superior endplate of T12. Lumbar Lordosis is reported in units of degrees. Negative angle corresponds to lordotic curvature, and positive angle corresponds to kyphotic curvature.

Coronal Balance will be measured from the PA TL Spine radiograph. A vertical line is drawn down from the center of the C7 vertebral body (C7PL), and a vertical line is drawn up from the center of the superior endplate of S1 (also known as the center sacral vertical line; "CSVL"). The distance between these lines is recorded in units of millimeters. The sign is positive if C7PL falls to right of the CSVL and negative if it falls to the left as viewed on the PA image.

Sagittal Balance will be measured from the Lateral TL Spine radiograph. A vertical line is drawn down from the center of the C7 vertebral body (also known as the Sagittal C7 plumb line, "Sagittal C7PL"), and a vertical line drawn from the posterior-superior corner of S1. The distance between these lines is recorded in units of millimeters. The sign is positive if the plumb line falls anterior to the posterior-superior corner of S1 and negative if it falls posterior.

Total Vertical Thoracic Spine Height will be calculated from the PA TL Spine radiograph. Total Vertical Thoracic Spine Height is defined as the vertical distance between the level of the midpoint of the superior endplate of T1 and the midpoint of the inferior endplate of T12 and will be reported in units of centimeters.

Total Vertical Spine Height will be calculated from the PA TL Spine radiograph. Total Vertical Spine Length is defined as the vertical distance between the level of the midpoint of the superior endplate of the T1 superior endplate and the midpoint of the superior endplate of S1 and will be reported in units of centimeters.

SRS-22 has 5 domains: function/activity (5 questions), pain (5 questions), self-image (5 questions), mental health (5 questions), and satisfaction with treatment (2 questions). Each question is scored from 1 (worst) to 5 (best). Domain scores are calculated by dividing the sum of answered questions by the number of items answered. The total score is the sum of all answered questions divided by the total number of items answered. Domain and total scores range from 1 (worst) to 5 (best), following the official SRS-22 scoring guidelines: https://www.srs.org/Files/Research/srs-22\_sample.pdf

Return to full activity was assessed using the two Function/Activity items of the SRS-22 questionnaire related to activity level: "What is your current level of activity?" and "What is your current level of work/school activity?". For each question, all possible response options-corresponding to scores from 1 (worst) to 5 (best)-were reported together with the distribution of patient answers. Results are presented as the percentage of patients selecting each response option (e.g., 30% selected score 3).

Radiographic Cobb Angles are calculated from the PA (posteroanterior) TL (thoracic/lumbar) spine radiograph and are reported in units of degrees. A positive angle indicates a curve where the apex is to the subject's right of the adjacent vertebra i.e. the angle opens to the subject's left. A negative angle indicates a curve where the apex is to the subject's left of the adjacent vertebra, i.e., the angle opens to the subject's right.

Radiographic assessments performed by the study site according to their standard of care.

Thoracic Kyphosis is calculated from the Lateral TL Spine radiograph and is measured as the angle between the superior endplate of T5 and the inferior endplate of T12. Thoracic Kyphosis is reported in units of degrees. Positive angle corresponds to kyphotic curvature, whereas negative angle corresponds to lordotic curvature.

Radiographic assessments performed by the study site according to their standard of care.

Lumbar Lordosis is calculated from the Lateral TL Spine radiograph and is measured as the angle between the superior endplate of S1 and the superior endplate of T12. Lumbar Lordosis is reported in units of degrees. Negative angle corresponds to lordotic curvature, and positive angle corresponds to kyphotic curvature.

Radiographic assessments performed by the study site according to their standard of care.

Coronal Balance is measured from the PA TL Spine radiograph. A vertical line is drawn down from the center of the C7 vertebral body (C7PL), and a vertical line is drawn up from the center of the superior endplate of S1 (also known as the center sacral vertical line; "CSVL"). The distance between these lines is recorded in units of millimeters. The sign is positive if C7PL falls to right of the CSVL and negative if it falls to the left as viewed on the PA image.

Radiographic assessments performed by the study site according to their standard of care.

Sagittal Balance is measured from the Lateral TL Spine radiograph. A vertical line is drawn down from the center of the C7 vertebral body (also known as the Sagittal C7 plumb line, "Sagittal C7PL"), and a vertical line drawn from the posterior-superior corner of S1. The distance between these lines is recorded in units of millimeters. The sign is positive if the plumb line falls anterior to the posterior-superior corner of S1 and negative if it falls posterior.

Radiographic assessments performed by the study site according to their standard of care.

Total Vertical Thoracic Spine Height and Total Vertical Spine Height are calculated from the PA TL Spine radiograph and are reported in units of centimeters.

Total Vertical Thoracic Spine Height is defined as the vertical distance between the level of the midpoint of the superior endplate of T1 and the midpoint of the inferior endplate of T12.

Total Vertical Spine Height is defined as the vertical distance between the level of the midpoint of the superior endplate of the T1 superior endplate and the midpoint of the superior endplate of S1.

Radiographic assessments performed by the study site according to their standard of care.

SRS-22 has 5 domains: function/activity (5 questions), pain (5 questions), self-image (5 questions), mental health (5 questions), and satisfaction with treatment (2 questions). Each question is scored from 1 (worst) to 5 (best). Domain scores are calculated by dividing the sum of answered questions by the number of items answered. The total score is the sum of all answered questions divided by the total number of items answered. Domain and total scores range from 1 (worst) to 5 (best), following the official SRS-22 scoring guidelines: https://www.srs.org/Files/Research/srs-22\_sample.pdf

Procedure related adverse events are any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, related to the procedure.

Summary will be based on both Investigators and Medtronic relatedness assessment.

Some adverse events or treatment failures may lead to additional surgical interventions. Relatedness of these subsequent spinal surgical interventions will be assessed Total events and total number of subjects who have additional surgeries will be summarized. The numbers of revisions (total, preventive and non-preventive), removals, reoperations and other surgeries will also be summarized.

A relatedness determination will be made by the investigator to the original study device and the original study surgery to a subsequent surgical intervention.

4 out of 10 patients treated underwent additional surgeries. 1 patient withdrew from the study and underwent revision surgery after exiting the study; therefore, the related data is not included in this analysis.

A device deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labeling.

Main Thoracic Cobb Angle will be calculated from the PA (posteroanterior) TL (thoracic/lumbar) spine radiograph. Main Thoracic Cobb Angle is reported in units of degrees. A positive angle indicates a curve where the apex is to the subject's right of the adjacent vertebra, i.e. the angle opens to the subject's left. A negative angle indicates a curve where the apex is to the subject's left of the adjacent vertebra, i.e., the angle opens to the subject's right.

Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

Proximal Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Proximal Thoracic Cobb Angle is reported in units of degrees.

Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

Thoracolumbar/Lumbar Cobb Angle will be calculated from the PA TL spine radiograph. Thoracolumbar/Lumbar Cobb Angle will be reported in units of degrees.

Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

The Instrumented Cobb Angle will be calculated from the PA TL Spine radiograph. It will be measured by drawing lines through the superior endplate of the upper instrumented vertebra and the inferior endplate of lower instrumented vertebra. The Instrumented Cobb Angle upper and lower end vertebrae will be defined at PostOp and maintained for all follow-up measurements. Instrumented Cobb Angle will be reported in units of degrees.

Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

Thoracic Kyphosis will be calculated from the Lateral TL Spine radiograph and will be measured as the angle between the superior endplate of T5 and the inferior endplate of T12. Thoracic Kyphosis is reported in units of degrees. Positive angle corresponds to kyphotic curvature, whereas negative angle corresponds to lordotic curvature.

Change from baseline for Thoracic Kyphosis was analyzed considering 3 groups: subjects with positive values at baseline (kyphotic), subjects with negative values at baseline (lordotic), and all subjects with absolute values. Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

Lumbar Lordosis will be calculated from the Lateral TL Spine radiograph and will be measured as the angle between the superior endplate of S1 and the superior endplate of T12. Lumbar Lordosis is reported in units of degrees. Negative angle corresponds to lordotic curvature, and positive angle corresponds to kyphotic curvature.

Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

Coronal Balance will be measured from the PA TL Spine radiograph. A vertical line is drawn down from the center of the C7 vertebral body (C7PL), and a vertical line is drawn up from the center of the superior endplate of S1 (also known as the center sacral vertical line; "CSVL"). The distance between these lines is recorded in units of millimeters. The sign is positive if C7PL falls to right of the CSVL and negative if it falls to the left as viewed on the PA image.

Change from baseline for Coronal Balance was analyzed considering 3 groups: subjects with positive values at baseline, subjects with negative values at baseline, and all subjects with absolute values. Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

Sagittal Balance will be measured from the Lateral TL Spine radiograph. A vertical line is drawn down from the center of the C7 vertebral body (also known as the Sagittal C7 plumb line, "Sagittal C7PL"), and a vertical line drawn from the posterior-superior corner of S1. The distance between these lines is recorded in units of millimeters. The sign is positive if the plumb line falls anterior to the posterior-superior corner of S1 and negative if it falls posterior.

Change from baseline for Sagittal Balance was analyzed considering 3 groups: subjects with positive values at baseline, subjects with negative values at baseline, and all subjects with absolute values. Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

Total Vertical Thoracic Spine Height will be calculated from the PA TL Spine radiograph. Total Vertical Thoracic Spine Height is defined as the vertical distance between the level of the midpoint of the superior endplate of T1 and the midpoint of the inferior endplate of T12 and will be reported in units of centimeters.

Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

Total Vertical Spine Height will be calculated from the PA TL Spine radiograph. Total Vertical Spine Length is defined as the vertical distance between the level of the midpoint of the superior endplate of the T1 superior endplate and the midpoint of the superior endplate of S1 and will be reported in units of centimeters.

Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.

SRS-22 has 5 domains: function/activity (5 questions), pain (5 questions), self-image (5 questions), mental health (5 questions), and satisfaction with treatment (2 questions). Each question is scored from 1 (worst) to 5 (best). Domain scores are calculated by dividing the sum of answered questions by the number of items answered. The total score is the sum of all answered questions divided by the total number of items answered. Domain and total scores range from 1 (worst) to 5 (best), following the official SRS-22 scoring guidelines: https://www.srs.org/Files/Research/srs-22\_sample.pdf

1 patient did not complete the questionnaire at 3-Month Follow-up (protocol deviation) and withdrew from the study before 18 Month Follow-up

Return to full activity was assessed using the two Function/Activity items of the SRS-22 questionnaire related to activity level: "What is your current level of activity?" and "What is your current level of work/school activity?". For each question, all possible response options-corresponding to scores from 1 (worst) to 5 (best)-were reported together with the distribution of patient answers. Results are presented as the percentage of patients selecting each response option (e.g., 30% selected score 3).

1 patient did not complete the questionnaire at 3-Month Follow-up (protocol deviation)

CURVE PROGRESSION

APNEIC EVENT POST-OP