Post-market surveillance of gelatin-thrombin hemostats in neurosurgery: a 10-year MAUDE Analysis.

OBJECTIVES

Flowable gelatin - thrombin matrix hemostats (Floseal® and Surgiflo®) are ubiquitous in cranial and spinal surgery, yet neurosurgical post-market safety data are limited. We describe adverse-event signals in a 10-year FDA Manufacturer and User Facility Device Experience (MAUDE) cohort.

METHODS

All MAUDE reports referencing Floseal or Surgiflo from January 2015 to December 2024 were ingested, deduplicated, and classified through the MAUDE-DASH pipeline. Structured event codes and deterministic narrative screening were mapped to pre-specified clinical categories and stratified.

RESULTS

Of 254 Floseal and 194 Surgiflo reports identified, 77 of 254 Floseal (30.3%) and 98 of 194 Surgiflo (50.5%) reports described neurosurgical use; spinal procedures predominated in both cohorts (Floseal 48/77, 62.3%; Surgiflo 82/98, 83.7%). Injury was the predominant MAUDE event-type designation. Within the Floseal cohort, neurologic deficit was described in 14/77 (18.2%) and CSF obstruction in 4/77 (5.2%); within the Surgiflo cohort, infection was described in 23/98 (23.5%) and mass effect in 40/98 (40.8%).

DISCUSSION: MAUDE narratives describe distinct within-cohort distributions of clinical categories. Reports of compressive neurologic deficits accounted for a larger proportion of the granular bovine-derived Floseal cohort, biologically consistent with the matrix's volumetric expansion in confined corridors. Reports of postoperative infection and mass-effect accumulation accounted for a larger proportion of the flowable porcine-derived Surgiflo cohort, biologically consistent with broader spread along surgical planes and a larger retained substrate surface. These hypothesis-generating findings reinforce the importance of meticulous intraoperative matrix removal and washout in anatomically constrained neural corridors and support continued post-market surveillance.