| Commonly Reported AEs Through Month 84 |
Mobi-C |
Fusion |
| Neck pain |
41.0% |
61.0% |
| Arm pain |
25.6% |
30.5% |
| Neck and arm pain |
5.1% |
7.6% |
| Back pain |
36.8% |
32.4% |
| Shoulder pain |
29.1% |
42.9% |
| Headache |
27.4% |
27.6% |
| Neurological - upper extremity sensory |
42.7% |
53.3% |
| Neurological - neck |
20.5 |
21.0% |
| Dysphagia |
17.1% |
22.9% |
| Dysphonia |
2.6% |
1.9% |
| Surgical wound infection |
3.4% |
3.8% |
| Nonunion (ACDF only) |
- |
14.3% |
| Heterotopic ossification rate at index levels (Mobi-C only) |
8.5% |
- |
| Unanticipated adverse device effect |
0.9% |
3.8% |
Note: Adverse event data includes the Mobi-C non-randomized training cases.