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.