AEs and complication SAEs.
| Category | ≤90 d Postoperatively | >90 d Postoperative | ||
| Patients, n (%) | No. of Events | Patients, n (%) | No. of Events | |
| Medical AE | 6 (9%) | 8 | 3 (4%) | 4 |
| Medical complication (SAE) | 2 (3%) | 2a | 0 | 0 |
| Surgical AE | 6 (9%) | 9 | 1 (1.5%) | 1b |
| Surgical complication (SAE) | ||||
| Prolonged surgery/recovery | 8 (12%) | 8c | 0 | 0 |
| Reoperation | 2 (3%) | 2d | 1 (1.5%) | 1e |
Abbreviations: AE, adverse event; DVT, deep vein thrombosis; PJK, proximal junctional kyphosis; SAE, serious adverse event.
Note: None of reported AEs or complications were related to personalized interbody devices.
↵a Postoperative DVT (2).
↵b Adjacent segment disease treated nonoperatively, 18 months postoperatively (1).
↵c Vascular injury (2), dural tear (2), pneumothorax (1), anemia (1), seroma (1), and lymphocele (1).
↵d Screw malposition or loosening (2).
↵e Mechanical complication: adjacent segment disease with PJK (1), reoperation 9 months postoperatively.