Table 3.
Overall AEs recorded in the whole population, categorized in intra and postoperative.
| INTRAOPERATIVE | Overall | Ped | Adults |
|---|---|---|---|
| Total intraoperative, n (%) | 24 (6.9%) | 4 (7.7%) | 20 (6.8%) |
| Allergic reaction, n (%) | 3 (0.9%) | 1 (1.9%) | |
| Cord injury, n (%) | 1 (0.3%) | 1 (1.9%) | |
| Dural tear, n (%) | 9 (2.6%) | 9 (3.1%) | |
| Hardware malp. requiring revision, n (%) | 4 (1.2%) | 1 (1.9%) | 3 (1.0%) |
| Hypotension, n (%) | 1 (0.3%) | 1 (1.9%) | |
| Massive blood loss, n (%) | 4 (1.2%) | 1 (1.9%) | 3 (1.0%) |
| Vascular injury, n (%) | 2 (0.6%) | 2 (0.7%) | |
| Airway/ventilation, n (%) | 1 (0.3%) | 1 (1.9%) | |
| Other, n (%) |
2 (0.6%) |
2 (0.7%) |
|
| POSTOPERATIVE | Overall | Ped | Adults |
| Total postoperative, n (%) | 48 (13.9%) | 7 (13.5%) | 41 (13.9%) |
| Cardiac arrest/failure/arrhythmia, n (%) | 3 (0.9%) | 3 (1.0%) | |
| Construct failure with loss of correc., n (%) | 3 (0.9%) | 3 (1.0%) | |
| CSF leak/meningocele, n (%) | 1 (0.3%) | 1 (0.3%) | |
| Deep wound infection, n (%) | 3 (0.9%) | 3 (1.0%) | |
| Dysphagia, n (%) | 1 (0.3%) | 1 (0.3%) | |
| Hematoma, n (%) | 1 (0.3%) | 1 (0.3%) | |
| Neurologic det. ≥ 1 motor grade, n (%) | 10 (2.9%) | 3 (5.8%) | 7 (2.4%) |
| Postop. neuropathic pain, n (%) | 14 (4.0%) | 14 (4.8%) | |
| Wound dehiscence, n (%) | 1 (0.3%) | 1 (0.3%) | |
| Other, n (%) | 15 (4.3%) | 4 (7.7%) | 11 (3.7%) |