{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T14:09:51Z","timestamp":1790690991377,"version":"4.1.0"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:00:00Z","timestamp":1789084800000},"content-version":"vor","delay-in-days":72,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["aao-hnsfjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["OTO Open"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design<\/jats:title>\n                    <jats:p>Retrospective database analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 90 AEs were identified across 4 implant types. Porous polyethylene SynPor\u00ae accounted for 69 events (76.7%), followed by porous polyethylene MEDPOR TITAN\u00ae with 15 (18.1%), porous polyethylene Su\u2010Por\u00ae with 4 (4.8%), and smooth nylon foil SupraFOIL\u00ae with 2 (2.4%). Most AEs were categorized as malfunctions (n\u2009=\u200964, 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\u2010based devices. No AEs were reported for titanium, poly\u2010\n                      <jats:sc>L<\/jats:sc>\n                      \/\n                      <jats:sc>DL<\/jats:sc>\n                      \u2010lactide, polycaprolactone, or PDS implants.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Within the MAUDE database, AEs were most frequently reported for porous polyethylene implants. These findings represent the first systematic characterization of MAUDE\u2010reported 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\u2010specific complication rates and further guide implant selection.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/oto2.70301","type":"journal-article","created":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T18:47:10Z","timestamp":1789152430000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Exploring Complications of Orbital Floor Reconstructive Implants Using the MAUDE Database"],"prefix":"10.1002","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4467-3277","authenticated-orcid":false,"given":"Emily S.","family":"Sagalow","sequence":"first","affiliation":[{"name":"Department of Otolaryngology\u2013Head and Neck Surgery University of Nevada Las Vegas Nevada USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head and Neck Surgery University of Nevada Las Vegas Nevada USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-6306-6220","authenticated-orcid":false,"given":"Samir","family":"Alkhouri","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head and Neck Surgery University of Nevada Las Vegas Nevada USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7506-1874","authenticated-orcid":false,"given":"Harry H.","family":"Ching","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head and Neck Surgery University of Nevada Las Vegas Nevada USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,11]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.7181\/acfs.2016.17.3.111"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1651514"},{"issue":"1","key":"e_1_2_8_4_1","first-page":"1991","article-title":"Materials used for reconstruction after orbital floor fracture","volume":"23","author":"Avashia YJ","year":"2012","journal-title":"J Craniofac Surg"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/PRS.0000000000000719"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/SAP.0b013e31820b3c7a"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/SCS.0b013e3181e57241"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/SCS.0000000000009871"},{"key":"e_1_2_8_9_1","unstructured":"SYNPOR\u00ae POROUS POLYETHYLENE IMPLANTS For craniofacial and orbital augmentation and reconstruction. www.depuysynthes.com. 2021. Accessed January 15 2026.https:\/\/www.jnjmedtech.com\/sites\/default\/files\/user_uploaded_assets\/pdf_assets\/2023-08\/DSUSMOC04140013%20Rev%20B.pdf"},{"key":"e_1_2_8_10_1","unstructured":"Stryker. MEDPOR TITAN 3D Orbital Floor A Stryker Exclusive Solution. www.stryker.com. 2016. Accessed January 15 2026.https:\/\/cmf.stryker.com\/assets\/files\/3c\/cmf-fl-6-medpor-titan-brand-yellow.pdf"},{"key":"e_1_2_8_11_1","unstructured":"Porous Polyethylene Membrane Sheet\u2013 Universal SU\u2010POR\u00ae Solution. Poriferous. September 24 2025. Accessed January 14 2026.https:\/\/poriferous.com\/porous-polyethylene-membrane-sheet\/"},{"key":"e_1_2_8_12_1","unstructured":"Supramid. SUPRAFOIL\u00ae smooth nylon foil \u2010 small. Supramid. 2026. Accessed January 14 2026.https:\/\/www.supramid.com\/suprafoil-smooth-nylon-foil-small"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/IOP.0000000000001829"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000003819"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcms.2015.06.022"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.sap.0000199173.73610.bc"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/SCS.0000000000003864"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcms.2016.11.020"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/SCS.0b013e3182413edc"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/SCS.0000000000009231"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1097\/SCS.0000000000000441"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0034-1371774"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.joms.2015.09.023"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1639350"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1177\/1943387520939032"}],"container-title":["OTO Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/aao-hnsfjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/oto2.70301","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aao-hnsfjournals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/oto2.70301","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aao-hnsfjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/oto2.70301","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T13:34:30Z","timestamp":1790688870000},"score":1,"resource":{"primary":{"URL":"https:\/\/aao-hnsfjournals.onlinelibrary.wiley.com\/doi\/10.1002\/oto2.70301"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":24,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1002\/oto2.70301"],"URL":"https:\/\/doi.org\/10.1002\/oto2.70301","archive":["Portico"],"relation":{},"ISSN":["2473-974X","2473-974X"],"issn-type":[{"value":"2473-974X","type":"print"},{"value":"2473-974X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"2025-10-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-04","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70301"}}