Intraoperative and postoperative adverse events related to interspinous process devices.
| Complications | Across Implantsa | Within Implantsb | |||||
| Coflex | Superion | X-Stop | Overall, % (n) | Coflex | Superion | X-Stop | |
| Intraoperative | 2.0% | 97.0% | 1.0% | 42.8% (404) | 21.1% | 47.3% | 5.2% |
| Implant malfunction | 2.1% | 97.6% | 0.3% | 39.7% (374) | 21.1% | 44.1% | 1.3% |
| Fracture | 0.0% | 85.7% | 14.3% | 2.2% (21) | 0.0% | 2.2% | 3.9% |
| Dural tear | 0.0% | 100.0% | 0.0% | 0.6% (6) | 0.0% | 0.7% | 0.0% |
| Hemorrhage | 0.0% | 100.0% | 0.0% | 0.2% (2) | 0.0% | 0.2% | 0.0% |
| Implant migration | 0.0% | 100.0% | 0.0% | 0.1% (1) | 0.0% | 0.1% | 0.0% |
| Postoperative | 5.6% | 80.9% | 13.5% | 57.2% (539) | 78.9% | 52.7% | 94.8% |
| Inadequate efficacy | 4.4% | 78.9% | 16.7% | 26.6% (251) | 28.9% | 23.9% | 54.5% |
| Implant migration | 2.8% | 89.4% | 7.8% | 19.1% (180) | 13.2% | 19.4% | 18.2% |
| Fracture | 7.8% | 78.1% | 14.1% | 6.8% (64) | 13.2% | 6.0% | 11.7% |
| Infection or wound healing | 26.7% | 60.0% | 13.3% | 3.2% (30) | 21.1% | 2.2% | 5.2% |
| Neurological complication | 7.7% | 61.5% | 30.8% | 1.4% (13) | 2.6% | 1.0% | 5.2% |
| Epidural hematoma | 0.0% | 100.0% | 0.0% | 0.1% (1) | 0.0% | 0.1% | 0.0% |
↵a Across group analysis demonstrates that the proportion of total adverse events for a given adverse event type is attributed to each implant manufacturer.
↵b Within groups analysis demonstrates the contribution of each adverse event to the total adverse events pool for a given manufacturer/implant.