Spinopelvic Fixation Using an Osseointegrative Implant: Analysis of Postmarket Surveillance to Determine the Failure Rate.

Background: Adult spinal deformities, affecting up to 60% of individuals older than 60 years, often require long segment fusions. Constructs spanning the lumbosacral junction commonly include pelvic fixation. Despite robust pelvic fixation, distal junctional failure, such as pseudoarthrosis, bone fracture, and instrumentation failure, occurs in 24%-34% of these cases. A novel implant designed for both durable pelvic fixation and sacroiliac joint fusion was recently cleared by the US Food and Drug Administration. This implant is engineered to address some of the pelvic fixation failure mechanisms by reducing motion at the lumbosacral junction and sacroiliac joint while decreasing stress on S1 pedicle screws and S2AI implants.

Objective: To determine the failure rate of a novel osseointegrative implant for spinopelvic fixation/fusion.

Study Design: Analysis of manufacturer postmarket surveillance database.

Methods: A postmarket surveillance database was analyzed to determine the type and rate of complaints and revisions of a novel osseointegrative implant. These were then compared with the published literature.

Results: A total of 15,628 implants were identified in 6907 patients. The postmarket surveillance of the novel screw fusion device revealed a low complaint rate of 0.75% and no postoperative implant breakage. Revision procedures were mostly due to set screw dissociation (0.4%) and implant loosening (0.15%), which was primarily linked to pre-existing conditions or infection. The mean (SD) time from index procedure to the complaint was 7.1 (5.4) months.

Conclusions: Compared with published literature, this novel osseointegrative implant demonstrates a significantly lower incidence of set screw dissociation than traditional pelvic screws with no incidence of breakage or back out, underscoring its durable integration with bone, with low rates of revisions and mechanical failures.

Clinical Relevance: A novel osseointegrative implant offers reduced rates of mechanical failures and revisions, helping to reduce complications in pelvic fixation procedures.