Table 4

Reasons for revision after placement of interspinous process devices.

Revision (n = 460)Across Implantsa Within Implantsb
CoflexSuperionX-StopOverall, % (n)CoflexSuperionX-Stop
Inadequate efficacy4.2%87.4%8.4%46.7% (215)29.0%49.1%39.1%
Implant migration2.0%91.5%6.5%33.3% (153)9.7%36.6%21.7%
Fracture10.0%67.5%22.5%8.7% (40)12.9%7.0%19.6%
Infection or wound healing30.4%52.2%17.4%5.0% (23)22.6%3.1%8.7%
Implant malfunction38.9%55.6%5.6%3.9% (18)22.6%2.6%2.2%
Neurological complication10.0%50.0%40.0%2.2% (10)3.2%1.3%8.7%
Epidural hematoma0.0%100.0%0.0%0.2% (1)0.0%0.3%0.0%
IPD-specific complication6.6%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.