(019) Adverse Events Associated with Orbital Floor Implants: A National Perspective

Introduction: Orbital floor implants (OFI) are key to the meticulous reconstruction of orbit contour following facial trauma. Post-operative complications such as visual disturbances and enophthalmos have been reported in the literature but are only briefly and peripherally mentioned. Thus, we aim to fill this gap by characterizing OFI adverse events on a national level.

Methods: Retrospective review of data from the 2011-2021 Food and Drug Administration Manufacturer and User Facility Device Experience database. Device, adverse event, and treatment information were collected and categorized. Descriptive statistics were used to characterize the data.

Results: Our cohort of 44 adverse events was most frequently reported in 2015 (22.73%). These adverse events predominantly involved Synthes OFIs (63.64%), occurred intraoperatively (71.43%), and resulted in patient injury (70.45%). OFI physical defects were the most reported device problem (35.71%), and infectious/inflammatory processes (18.42%) and retained OFI parts (13.16%) were the most common patient problems. Adverse events were frequently treated by implant removal and replacement (34.15%) or by removal only (19.51%), resulting in delayed primary surgery in 25.64% of reported cases. Adverse event treatment exhibited a 19.35% complication rate.

Conclusions: Although orbital floor fractures often require acute management, intraoperative adverse events may result in patient injury and necessitate additional treatment. Careful OFI handling and precise surgical technique during orbital reconstruction may help improve patient outcomes and reduce cost of treatment. In light of adverse event under-reporting in otolaryngology, we also hope to raise awareness of its ability to improve patient counseling and standard of care.