Resultant outcome as a function of adverse event type related to interspinous process devices.
| Complications | Across Implantsa | Within Implantsb | Within Implants, as Percentage of Each Complicationc | ||||||||
| Coflex | Superion | X-Stop | Overall | Coflex | Superion | X-Stop | Coflex | Superion | X-Stop | Overall | |
| Implant malfunction | 2.1% | 97.6% | 0.3% | 39.7% | 21.1% | 44.1% | 1.3% | - | - | - | - |
| No clinical signs, symptoms, or conditions | 0.0% | 100.0% | 0.0% | 33.8% | 0.0% | 38.5% | 0.0% | 0.0% | 87.4% | 0.0% | 85.3% |
| Persistent pain | 2.9% | 97.1% | 0.0% | 3.6% | 2.6% | 4.0% | 0.0% | 12.5% | 9.0% | 0.0% | 9.1% |
| Revision | 38.9% | 55.6% | 5.6% | 1.9% | 18.4% | 1.2% | 1.3% | 87.5% | 2.7% | 100.0% | 4.8% |
| Procedure aborted | 0.0% | 100.0% | 0.0% | 0.3% | 0.0% | 0.4% | 0.0% | 0.0% | 0.8% | 0.0% | 0.8% |
| Inadequate efficacy | 4.4% | 78.9% | 16.7% | 26.6% | 28.9% | 23.9% | 54.5% | - | - | - | - |
| Revision | 4.2% | 87.4% | 8.4% | 22.8% | 23.7% | 22.7% | 23.4% | 81.8% | 94.9% | 42.9% | 85.7% |
| Persistent pain | 5.6% | 27.8% | 66.7% | 3.8% | 5.3% | 1.2% | 31.2% | 18.2% | 5.1% | 57.1% | 14.3% |
| Implant migration | 2.8% | 89.5% | 7.7% | 19.2% | 13.2% | 19.6% | 18.2% | - | - | - | - |
| Revision | 2.0% | 91.5% | 6.5% | 16.2% | 7.9% | 16.9% | 13.0% | 60.0% | 86.4% | 71.4% | 84.5% |
| Persistent pain | 7.7% | 84.6% | 7.7% | 2.8% | 5.3% | 2.7% | 2.6% | 40.0% | 13.6% | 14.3% | 14.4% |
| No clinical signs, symptoms, or conditions | 0.0% | 0.0% | 100.0% | 0.2% | 0.0% | 0.0% | 2.6% | 0.0% | 0.0% | 14.3% | 1.1% |
| Fracture | 5.9% | 80.0% | 14.1% | 9.0% | 13.2% | 8.2% | 15.6% | - | - | - | - |
| Revision | 10.0% | 67.5% | 22.5% | 4.2% | 10.5% | 3.3% | 11.7% | 80.0% | 39.7% | 75.0% | 47.1% |
| Persistent pain | 3.8% | 96.2% | 0.0% | 2.8% | 2.6% | 3.0% | 0.0% | 20.0% | 36.8% | 0.0% | 30.6% |
| Procedure aborted | 0.0% | 91.7% | 8.3% | 1.3% | 0.0% | 1.3% | 1.3% | 0.0% | 16.2% | 8.3% | 14.1% |
| No clinical signs, symptoms, or conditions | 0.0% | 71.4% | 28.6% | 0.7% | 0.0% | 0.6% | 2.6% | 0.0% | 7.4% | 16.7% | 8.2% |
| Infection or wound healing | 26.7% | 60.0% | 13.3% | 3.2% | 21.1% | 2.2% | 5.2% | - | - | - | - |
| Revision | 30.4% | 52.2% | 17.4% | 2.4% | 18.4% | 1.4% | 5.2% | 87.5% | 66.7% | 100.0% | 76.7% |
| Antibiotics | 14.3% | 85.7% | 0.0% | 0.7% | 2.6% | 0.7% | 0.0% | 12.5% | 33.3% | 0.0% | 23.3% |
| Neurological complication | 7.7% | 61.5% | 30.8% | 1.4% | 2.6% | 1.0% | 5.2% | - | - | - | - |
| Revision | 10.0% | 50.0% | 40.0% | 1.1% | 2.6% | 0.6% | 5.2% | 100.0% | 62.5% | 100.0% | 76.9% |
| Neurological issue | 0.0% | 100.0% | 0.0% | 0.3% | 0.0% | 0.4% | 0.0% | 0.0% | 37.5% | 0.0% | 23.1% |
| Dural tear | 0.0% | 100.0% | 0.0% | 0.6% | 0.0% | 0.7% | 0.0% | - | - | - | - |
| Dura blood patch | 0.0% | 100.0% | 0.0% | 0.3% | 0.0% | 0.4% | 0.0% | - | 50.0% | - | 50.0% |
| Procedure aborted | 0.0% | 100.0% | 0.0% | 0.2% | 0.0% | 0.2% | 0.0% | - | 33.3% | - | 33.3% |
| Persistent pain | 0.0% | 100.0% | 0.0% | 0.1% | 0.0% | 0.1% | 0.0% | - | 16.7% | - | 16.7% |
| Hemorrhage | 0.0% | 100.0% | 0.0% | 0.2% | 0.0% | 0.2% | 0.0% | - | - | - | - |
| Procedure aborted | 0.0% | 100.0% | 0.0% | 0.2% | 0.0% | 0.2% | 0.0% | - | 100.0% | - | 100.0% |
| Epidural hematoma | 0.0% | 100.0% | 0.0% | 0.1% | 0.0% | 0.1% | 0.0% | - | - | - | - |
| Revision | 0.0% | 100.0% | 0.0% | 0.1% | 0.0% | 0.1% | 0.0% | - | 100.0% | - | 100.0% |
↵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.
↵c Within groups analysis as a percentage of each complication indicates the percentage of each outcome for each implant within a specific adverse event type.