{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T13:57:39Z","timestamp":1775743059720,"version":"3.50.1"},"reference-count":17,"publisher":"The Korean Society of Anesthesiologists","issue":"2","license":[{"start":{"date-parts":[[2021,4,19]],"date-time":"2021-04-19T00:00:00Z","timestamp":1618790400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["anesth-pain-med.org"],"crossmark-restriction":true},"short-container-title":["Anesth Pain Med"],"published-print":{"date-parts":[[2021,4,30]]},"abstract":"<jats:p>Background: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. Methods: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. Results: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain\/worsening symptoms. Conclusions: Further studies such as randomized controlled trials are needed to validate the findings. <\/jats:p>","DOI":"10.17085\/apm.20093","type":"journal-article","created":{"date-parts":[[2021,4,19]],"date-time":"2021-04-19T01:19:57Z","timestamp":1618795197000},"page":"177-183","update-policy":"https:\/\/doi.org\/10.17085\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data"],"prefix":"10.17085","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4351-7002","authenticated-orcid":true,"given":"Nitish","family":"Aggarwal","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7555-0830","authenticated-orcid":true,"given":"Robert","family":"Chow","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2573","reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.4103\/0019-5413.114909"},{"key":"ref2","first-page":"e5374","volume-title":"The use of Vertiflex<sup>\u00ae<\/sup> interspinous spacer device in patients with lumbar spinal stenosis and concurrent medical comorbidities","author":"Hartman","year":"2019"},{"key":"ref3","volume-title":"U.S. Food and Drug Administration [serial on the Internet]"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.7150\/ijms.4397"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1046\/j.0306-5251.2001.01501.x"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1002\/pds.677"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050466"},{"key":"ref8","first-page":"193","volume-title":"Use of measures of disproportionality in pharmacovigilance","author":"Belamalem","year":"2016"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1177\/2168479015589822"},{"key":"ref10","volume-title":"Primer on disproportionality analysis. OpenVigil [serial on the Internet]","author":"B\u00f6hm"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1016\/j.clineuro.2018.06.030"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1111\/papr.12744"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.2174\/1874325001105010361"},{"key":"ref14","first-page":"275","volume-title":"Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial","author":"Patel","year":"2015"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.3171\/2010.3.focus1047"},{"key":"ref16","first-page":"4497","volume-title":"Comparison of two interspinous spacers for treatment of moderate lumbar spinal stenosis: a meta-analysis of prospective randomized controlled trials","author":"Ma","year":"2017"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1111\/dth.13221"}],"container-title":["Anesthesia and Pain Medicine"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/anesth-pain-med.org\/upload\/pdf\/apm-20093.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/anesth-pain-med.org\/journal\/view.php?doi=10.17085\/apm.20093","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/anesth-pain-med.org\/upload\/pdf\/apm-20093.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,30]],"date-time":"2021-04-30T07:15:32Z","timestamp":1619766932000},"score":1,"resource":{"primary":{"URL":"http:\/\/anesth-pain-med.org\/journal\/view.php?doi=10.17085\/apm.20093"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,30]]},"references-count":17,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,4]]}},"URL":"https:\/\/doi.org\/10.17085\/apm.20093","relation":{},"ISSN":["1975-5171","2383-7977"],"issn-type":[{"value":"1975-5171","type":"print"},{"value":"2383-7977","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,4,30]]},"assertion":[{"value":"2020-12-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-04-19","order":2,"name":"published","label":"Published online","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-04-30","order":3,"name":"published","label":"Print publication","group":{"name":"publication_history","label":"Publication History"}}]}}