Between March 2005 and March 2010, 9,152 patients underwent interbody fusion with the AxiaLIF System through an axial presacral approach. A single-level L5-S1 fusion was performed in 8,034 patients (88 % ), and a 2-level (L4-S1) fusion was used in 1,118 (12 % ). A predefined database was designed to record device- or procedure-related complaints via spontaneous reporting. The complications that were recorded included bowel injury, superficial wound and systemic infections, transient intraoperative hypotension, migration, subsidence, presacral hematoma, sacral fracture, vascular injury, nerve injury, and ureter injury.
Complications were reported in 120 of 9,152 patients (1.3 % ). The most commonly reported complications were bowel injury (n = 59, 0.6 % ) and transient intraoperative hypotension (n = 20, 0.2 % ). The overall complication rate was similar between single-level (n = 102, 1.3 % ) and 2-level (n = 18, 1.6 % ) fusion procedures, with no significant differences noted for any single complication.
The 5-year postmarketing surveillance experience with the AxiaLIF System suggests that axial interbody lumbar fusion through the presacral approach is associated with a low incidence of complications. The overall complication rates observed in our evaluation compare favorably with those reported in trials of open and minimally invasive lumbar fusion surgery.