Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review

Povolotskiy, Roman; Abraham, Mickey; Leverant, Adam B; Bresler, Amishav Y.; Paskhover, Boris

doi:10.1016/j.amjoto.2019.102303

Cited by 2 publications

(2 citation statements)

References 19 publications

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“…From 336 articles, 21 that downloaded MAUDE data files were set aside for further analysis 11–31 . Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 .…”

Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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Objective This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Methods Studies using MAUDE data were sourced from PubMed by searching for “MAUDE” or “Manufacturer and User Facility Device Experience” in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. Results As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Conclusions Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

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Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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“…Furthermore, biodegradability and biosafety have been underappreciated in current artificial periosteum research, especially for polymer artificial periosteum. [ 8 ] Implantable biomaterials have been reported to cause adverse events, such as hypersensitivity, [ 9 ] patient pain, or foreign body sensations, [ 10 ] increasing the patients’ physiological and mental burden. To heal bone defects, creating an artificial periosteum with good osteogenic activity, biodegradable, and biosafe.…”

Section: Introductionmentioning

confidence: 99%

Cuttlebone‐Derived Organic Matrix: A Facile Periosteum Substitute for Bone Regeneration

Wei

Zheng

et al. 2023

Adv Funct Materials

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Artificial periosteum has become a novel strategy for bone healing. Several efforts are made to develop novel periosteum substitutes with excellent osteogenesis and angiogenesis performance. The problem, however, is that many inconveniences, such as unattainable materials and complex preparation processes, limit its clinical application. In this study, cuttlebone-derived organic matrix (CDOM) film is developed as a facile obtained artificial periosteum with good bioactivity, biodegradability, and biosafety. In this study, CDOM films are prepared by etching calcium carbonate of cuttlebone with hydrochloric acid (HCl), phosphoric acid (H 3 PO 4 ), and ethylenediaminetetraacetic acid (EDTA), respectively. CDOM films possess "S" oriented grooves on one surface, providing suitable space for survival, adhesion, and proliferation of rat mesenchymal stem cells and human umbilical vein endothelial cells. Among three CDOM films, CDOM-EDTA is the most efficient at enhancing bone regeneration in vivo, with an increase in neovascularization and new bone formation. Meanwhile, CDOM-EDTA is degradable in two months and of extremely low toxicity. There is a great deal of promise in the future for this novel periosteum substitute to be used for bone defect healing in clinical settings.

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Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review

Cited by 2 publications

References 19 publications

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Cuttlebone‐Derived Organic Matrix: A Facile Periosteum Substitute for Bone Regeneration

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