S6B-05 SESSION 6B: HFM ROBIN - PART I DEVICE MALFUNCTION DURING MANDIBULAR DISTRACTION IN INFANTS WITH ROBIN SEQUENCE. Article Swipe
YOU?
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· 2019
· Open Access
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· DOI: https://doi.org/10.1097/01.gox.0000583456.89570.7d
Introduction: Mandibular distraction osteogenesis (MDO) has been increasingly used in infants with severe upper airway obstruction associated with Robin sequence (RS). By enabling gradual mandibular lengthening and soft tissue stretching, this procedure effectively opens the upper airway. The most common devices used in MDO have internal and external components that require manual activation, often performed by health care providers and/or adult family members. These distractors undergo rigorous examination and testing by the various companies, prior to clearance by the Federal Drug Administration. Although complications associated with MDO in infants with RS have been well documented, there is a paucity of literature precisely describing hardware/device malfunction. The current study reports on the authors’ recent experiences with these problems, in an effort to shed light on these complications and identify potential steps to mitigate future issues. Methods: The authors retrospectively reviewed a prospectively gathered database to identify all young children under the age of 3 years, who underwent MDO using buried internal devices for severe upper airway obstruction associated with RS from March, 2007 to October, 2018. We specifically focused on complications attributable to the hardware itself. Discussions were held with the company representatives to better understand these problems, troubleshoot the issues at hand, and seek avenues for future improvement. Results: A total of 13 patients met inclusion criteria. Six (46.2%) patients developed complications related to the device. The mean age at mandibular osteotomies was 29.52 ± 40.54 (range 3.14, 117.29) weeks. Intraoperative activation of all devices under direct vision resulted in satisfactory distraction. Postoperative complications included unilateral device break down of component parts (N=3), unilateral failure to distract (N=2) and bilateral failure to distract (N=1). Two patients required removal and replacement of the device. The remaining patients were conservatively managed by changing the degree or direction of advancement. Conclusion: This report documents a series of device/hardware defects in young children undergoing MDO for upper airway obstruction associated with RS. Despite all reasonable testing and development, these distractors may malfunction, resulting in patient morbidity. Our institution is currently working with device manufacturers to address these complications in effort to improve quality control and minimize risk of future adverse events.
Related Topics
- Type
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- Language
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- https://doi.org/10.1097/01.gox.0000583456.89570.7d
- OA Status
- gold
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- OpenAlex ID
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Raw OpenAlex JSON
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https://openalex.org/W2972389285Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1097/01.gox.0000583456.89570.7dDigital Object Identifier
- Title
-
S6B-05 SESSION 6B: HFM ROBIN - PART I DEVICE MALFUNCTION DURING MANDIBULAR DISTRACTION IN INFANTS WITH ROBIN SEQUENCE.Work title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2019Year of publication
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2019-08-01Full publication date if available
- Authors
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Mónica Manrique, Esperanza Mantilla‐Rivas, Michael K. Boyajian, Justin R. Bryant, Gary F. Rogers, Albert K. OhList of authors in order
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https://doi.org/10.1097/01.gox.0000583456.89570.7dPublisher landing page
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://doi.org/10.1097/01.gox.0000583456.89570.7dDirect OA link when available
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Airway obstruction, Medicine, Airway, Session (web analytics), Distraction, Pediatrics, Surgery, Psychology, Computer science, World Wide Web, NeuroscienceTop concepts (fields/topics) attached by OpenAlex
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0Total citation count in OpenAlex
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10Other works algorithmically related by OpenAlex
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| institutions_distinct_count | 6 |
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