OTO open · 2026
Exploring Complications of Orbital Floor Reconstructive Implants Using the MAUDE Database.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Sagalow Emily S, Liu Caroline, Alkhouri Samir, Ching Harry H
Аннотация
OBJECTIVE: Orbital floor fractures are commonly treated with alloplastic implants, yet comparative safety data on implant materials remain limited. This study evaluates the adverse event (AE) profiles of commonly used orbital floor implants using a national device surveillance database.
STUDY DESIGN: Retrospective database analysis.
SETTING: Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS: The MAUDE database was queried for AEs related to 13 orbital floor reconstructive implants from 7 manufacturers. Reported events were categorized by implant type and classified as malfunction, injury, or other.
RESULTS: A total of 90 AEs were identified across 4 implant types. Porous polyethylene SynPor® accounted for 69 events (76.7%), followed by porous polyethylene MEDPOR TITAN® with 15 (18.1%), porous polyethylene Su-Por® with 4 (4.8%), and smooth nylon foil SupraFOIL® with 2 (2.4%). Most AEs were categorized as malfunctions (n = 64, 77.1%), while 19 (21.1%) were reported as injuries. No malfunctions resulted in patient harm. All reported cases of implant infection or extrusion occurred with polyethylene implants. Overall, 97.6% of AEs involved polyethylene-based devices. No AEs were reported for titanium, poly-l/ dl-lactide, polycaprolactone, or PDS implants.
CONCLUSION: Within the MAUDE database, AEs were most frequently reported for porous polyethylene implants. These findings represent the first systematic characterization of MAUDE-reported AEs for orbital floor implants and identify porous polyethylene as the predominant implant type captured in national postmarket surveillance. Prospective comparative studies are needed to evaluate material-specific complication rates and further guide implant selection.
STUDY DESIGN: Retrospective database analysis.
SETTING: Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS: The MAUDE database was queried for AEs related to 13 orbital floor reconstructive implants from 7 manufacturers. Reported events were categorized by implant type and classified as malfunction, injury, or other.
RESULTS: A total of 90 AEs were identified across 4 implant types. Porous polyethylene SynPor® accounted for 69 events (76.7%), followed by porous polyethylene MEDPOR TITAN® with 15 (18.1%), porous polyethylene Su-Por® with 4 (4.8%), and smooth nylon foil SupraFOIL® with 2 (2.4%). Most AEs were categorized as malfunctions (n = 64, 77.1%), while 19 (21.1%) were reported as injuries. No malfunctions resulted in patient harm. All reported cases of implant infection or extrusion occurred with polyethylene implants. Overall, 97.6% of AEs involved polyethylene-based devices. No AEs were reported for titanium, poly-l/ dl-lactide, polycaprolactone, or PDS implants.
CONCLUSION: Within the MAUDE database, AEs were most frequently reported for porous polyethylene implants. These findings represent the first systematic characterization of MAUDE-reported AEs for orbital floor implants and identify porous polyethylene as the predominant implant type captured in national postmarket surveillance. Prospective comparative studies are needed to evaluate material-specific complication rates and further guide implant selection.