Study-related serious adverse events.
| Study-Related Serious Adverse Event | n |
| Required secondary surgical intervention at index level | 6 |
| Required surgical intervention at an adjacent level | 3 |
| Hematoma requiring evacuation | 2 |
| Required intraoperative repair | 1 |
| Required hospitalization without surgical intervention | 3 |
| Device-related serious adverse events | 0 |
Includes two device explants