Postapproval Key Adverse Events and Overall Reoperation Rates Compared With the Investigational Device Exemption (IDE) Study
| 6 mos Post-FDA Approval (N = 1714) | 12 mos Post-FDA Approval (N = 4055) (Cumulative) | 18 mos Post-FDA Approval (N = 5575) (Cumulative) | IDE Study (N = 276) | |
|---|---|---|---|---|
| Adverse event, n (%) | ||||
| Anterior migration with reoperation | 1 (0.06) | 28 (0.69) | 36 (0.65) | 3 (1.09) |
| Sizing/malposition with reoperation | 2 (0.12) | 18 (0.44) | 20 (0.36) | 1 (0.36) |
| Bone fragment with reoperation | 0 | 2 (0.05) | 2 (0.04) | 0 |
| End plate fracture | 1 (0.06) | 6 (0.15) | 6 (0.11) | 0 |
| Posterior element fracture with reoperation | 1 (0.06) | 12 (0.30) | 17 (0.30) | 5 (1.81) |
| Subsidence with reoperation | 1 (0.06) | 5 (0.12) | 11 (0.20) | 0 |
| Posterior migration with reoperation | 1 (0.06) | 2 (0.05) | 4 (0.07) | 0 |
| Major vascular injury requiring transfusion | 2 (0.12) | 13 (0.32) | 13 (0.23) | 1 (0.36) |
| Major neurologicala | 0 | 5 (0.12) | 5 (0.09) | 13 (4.71) |
| Deep wound infection | 0 | 2 (0.05) | 2 (0.04) | 0 |
| Death | 1 (0.06) | 2 (0.05) | 3 (0.05) | 1 (0.36) |
| Total | 10 (0.58) | 95 (2.34) | 119 (2.13) | 24 (8.70) |
| Overall reoperations, n (%) | ||||
| Reoperations, 360-degree revisions, and off-label reoperations | 6 (0.35) | 67 (1.65) | 90 (1.61) | 15 (5.43) |
Note. FDA = Food and Drug Administration.
↵a As described by Geisler et al.4