دورية أكاديمية
أعرض في EDS

Characterizing complications associated with skull clamps: A review of the manufacturer and user facility device experience database.

التفاصيل البيبلوغرافية
العنوان: Characterizing complications associated with skull clamps: A review of the manufacturer and user facility device experience database.
المؤلفون: Shah HA; Department of Neurological Surgery, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA. Electronic address: hshah5@northwell.edu., Mehta NH; Harvard Medical School, Boston, MA, USA., Mehta SH; Department of Neurological Surgery, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA., Ward M; Department of Neurological Surgery, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA., McBriar JD; Department of Neurological Surgery, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA., D'Amico RS; Department of Neurological Surgery, Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA.
المصدر: Clinical neurology and neurosurgery [Clin Neurol Neurosurg] 2023 Dec; Vol. 235, pp. 108043. Date of Electronic Publication: 2023 Nov 04.
نوع المنشور: Review; Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 7502039 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-6968 (Electronic) Linking ISSN: 03038467 NLM ISO Abbreviation: Clin Neurol Neurosurg Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam : Elsevier
Original Publication: Assen, Van Gorcum.
مواضيع طبية MeSH: Lacerations*, Humans ; United States ; Surgical Instruments ; Skull ; Databases, Factual ; United States Food and Drug Administration
مستخلص: Objective: Head immobilization with skull clamps is a prerequisite of many neurosurgical procedures. Adverse events relating to the use of skull clamps have been reported, however, given the paucity of published reports, we sought to conduct a more comprehensive analysis using the Manufacturer and User Facility Device Experience (MAUDE) database.
Methods: The MAUDE database was queried for neurosurgical skull clamp events over a 10-year period between January 2013 and December 2022. Reports were qualitatively analyzed and categorically assigned by the study authors as 'mechanical failure,' 'slippage,' 'contamination,' 'insufficient information,' and 'other.' Patient injury reports were also classified as 'abrasion,' 'laceration,' 'hematoma,' 'fracture,' 'intracranial hemorrhage (ICH),' 'other,' 'insufficient information,' and 'death.'
Results: Of 3672 reports retrieved, 2689 (73.2%) were device malfunctions, with mechanical failure (50.7%) and slippage (47.7%) being the most common causes. There were 983 reports (26.8%) involving patient injury which included lacerations (n = 776, 78.9%), fractures (n = 24, 2.4%), abrasions (n = 23, 2.3%), hematomas (n = 7, 0.71%), ICH (n = 3, 0.31%), and other causes (n = 6, 0.61%). Five (0.1%) deaths due to skull clamp related complications were also reported.
Conclusions: This study provides a more comprehensive picture of adverse events in neurosurgical procedures relating to the use of skull clamps. Mechanical failures of device parts were the most common device-related complication, and lacerations the most common adverse patient-related event. While more severe patient-related events were reported, they are relatively rare. The MAUDE database is useful for characterizing underreported device-related and patient-related adverse events.
(Copyright © 2023 Elsevier B.V. All rights reserved.)
فهرسة مساهمة: Keywords: Head immobilization; MAUDE; Mayfield clamp; Neurosurgery
تواريخ الأحداث: Date Created: 20231109 Date Completed: 20231201 Latest Revision: 20240530
رمز التحديث: 20240531
DOI: 10.1016/j.clineuro.2023.108043
PMID: 37944306
قاعدة البيانات: MEDLINE
الوصف
تدمد:1872-6968
DOI:10.1016/j.clineuro.2023.108043