Adverse Events, Complications, and Secondary Surgical Intervention for Animal-Derived Resorbable Oral Barrier Membranes: A Report-Based Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (FDA MAUDE) Database

This is the authors' abstract. We don't add key points for this paper.

PurposeThis study aimed to characterize the complications described in adverse event reports for animal-derived resorbable barrier membranes [Food and Drug Administration (FDA) product code NPL] and to determine whether reports of infection or wound dehiscence would describe secondary surgical intervention more often than reports without either complication. Materials and MethodsReports received by the FDA Manufacturer and User Facility Device Experience (MAUDE) database over a ten-year period were identified.Three reviewers independently analyzed each included report and coded anatomic site, main adverse event, individual complications, interventions, Clavien-Dindo severity grade, device attribution, and report informativeness.Inter-rater agreement was measured with Fleiss kappa.The primary outcome was any secondary surgical intervention (membrane, graft, or implant removal, surgical revision, repeat grafting, or tooth extraction).Groups were compared with the Fisher exact test. ResultsGraft loss, dehiscence, and infection or abscess were the most frequent complications.Most reports described secondary surgical intervention, and most were graded Clavien-Dindo 3a.Reports related to dehiscence or infection described reintervention more often than reports with neither complication.Agreement between reviewers was high for most complications and interventions. ConclusionsIn MAUDE reports for animal-derived resorbable membranes, the cases that led to further surgery were mostly failures of soft tissue healing: dehiscence, infection, and the graft loss that often came with them.These reports skew toward severe cases and cannot be used to estimate how often complications occur.Structured reporting of surgical site, timing, and basic risk factors would make the database more useful for these devices.