Revision (n = 460) | Across Implantsa | Within Implantsb | |||||
Coflex | Superion | X-Stop | Overall, % (n) | Coflex | Superion | X-Stop | |
Inadequate efficacy | 4.2% | 87.4% | 8.4% | 46.7% (215) | 29.0% | 49.1% | 39.1% |
Implant migration | 2.0% | 91.5% | 6.5% | 33.3% (153) | 9.7% | 36.6% | 21.7% |
Fracture | 10.0% | 67.5% | 22.5% | 8.7% (40) | 12.9% | 7.0% | 19.6% |
Infection or wound healing | 30.4% | 52.2% | 17.4% | 5.0% (23) | 22.6% | 3.1% | 8.7% |
Implant malfunction | 38.9% | 55.6% | 5.6% | 3.9% (18) | 22.6% | 2.6% | 2.2% |
Neurological complication | 10.0% | 50.0% | 40.0% | 2.2% (10) | 3.2% | 1.3% | 8.7% |
Epidural hematoma | 0.0% | 100.0% | 0.0% | 0.2% (1) | 0.0% | 0.3% | 0.0% |
IPD-specific complication | 6.6% | 83.9% | 9.5% | 45.9% (211) | 45.2% | 46.2% | 43.5% |
Abbreviation: IPD, interspinous process device.
↵a The percentage of revisions attributed to each implant brand is shown for each revision indication.
↵b The percentage of overall revisions indicates the percentage of overall revisions attributed to each adverse event type. IPD-specific complications include implant migration, fracture, and implant malfunction.