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Can I read Characterizing complications associated with skull clamps: A review of the manufacturer and user facility device experience database on EtoBox?
Characterizing complications associated with skull clamps: A review of the manufacturer and user facility device experience database by Harshal A. Shah; Neel H. Mehta; Shyle H. Mehta; Max Ward; Joshua D. McBriar; Randy S. D’Amico is a Medicine article available to read on EtoBox.
What is Characterizing complications associated with skull clamps: A review of the manufacturer and user facility device experience database about?
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
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- Author
- Harshal A. Shah; Neel H. Mehta; Shyle H. Mehta; Max Ward; Joshua D. McBriar; Randy S. D’Amico
- Publisher
- Elsevier BV
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)