Adverse events involving mandibular hardware: an analysis of the Food and Drug Administration Facility Device Experience data

摘要

Purpose: To investigate frequencies and characteristics concerning mandibular device complications as reported to the Food and Drug Administration. Study Design: Retrospective database review. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports from 2007 to 2017 using the keywords 'mandible' and 'mandibular'. A total of 3592 reports were gathered. After curating out duplicate reports, reports not applicable to mandibular hardware, and literature articles, 1899 event device reports were subsequently studied for mandibular hardware. A side cohort of 192 TMJ device reports was analysed separately. Reports were reviewed based on both the device cited in the report and the concerns cited in the event text (i.e. an explanation of a plate fracture/failure or of an infection). Additional frequencies involving the company manufacturers and reported patient injury were also analysed.