(0516) Exploring Adverse Events of Orbital Floor Reconstructive Implants Using the MAUDE Database

Introduction: Traumatic orbital floor fractures which require surgical treatment are commonly repaired with alloplastic implants. Commonly utilized implant materials include non-porous or porous polyethylene with or without titanium, titanium alone, polydioxanone (PDS), and nylon foil. The aim of this study was to explore the adverse events (AEs) for various orbital floor reconstructive implants.

Methods: The Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database was searched for AEs related to 13 different orbital floor reconstructive implants from 7 different manufacturers. Events reported in the database were categorized.

Results: A total of 83 AEs were recorded for 4 implants with 62 (74.7%) for polyethylene implant SynPor®, 15 (18.1%) for polyethylene implant MEDPOR TITAN®, 4 (4.8%) for polyethylene implant Su-Por®, and 2 (2.4%) for smooth nylon foil implant SupraFOIL®. The majority of AE were categorized as “malfunction” (n = 64, 77.1%), followed by “injury” (n = 19, 22.9%). No “malfunction” implants caused harm to patients. All reported implant infections and extrusions occured with polyethylene implants. The majority (97.6%) of all reported AEs were associated with polyethylene implants. No AE were reported for titanium, poly-L/DL-lactide, polycaprolactone, or PDS implants.

Conclusions: The majority of AEs for the orbital floor reconstructive implants studied were categorized as “malfunction” resulting in nonuse of the implant. The most commonly reported “injury” was infection. The majority of reported AEs were associated with polyethylene implants. Further research regarding AE of all implant material types should be conducted so that providers may counsel patients and choose orbital floor reconstructive implants appropriately.