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Filename: helpers/my_audit_helper.php
Line Number: 197
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File: /var/www/html/application/helpers/my_audit_helper.php
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Function: file_get_contents
File: /var/www/html/application/helpers/my_audit_helper.php
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Function: simplexml_load_file_from_url
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Function: getPubMedXML
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Function: pubMedSearch_Global
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Function: pubMedGetRelatedKeyword
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Function: require_once
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Study Design: Cross-sectional study.
Objective: This study aimed to analyze the failure patterns of expandable corpectomy cages.
Summary Of Background Data: Expandable corpectomy cages offer significant advantages for anterior column reconstruction but introduce unique mechanical complexities. Device-specific failure patterns and their clinical implications remain poorly characterized in the literature.
Methods: We analyzed 373 adverse event reports involving expandable corpectomy cages from the FDA Manufacturer and User Facility Device Experience (MAUDE) database through October 2024. Using validated AI-assisted classification, reports were categorized by failure mode, anatomical location, revision status, and contributing factors. Chi-square tests with Bonferroni correction were used to assess associations between variables.
Results: Inserter-related issues constituted the most common adverse events (34.3%), yet rarely resulted in clinical symptoms (5.4%) or revision surgery (21.9%). Conversely, less frequent mechanical failures demonstrated significantly higher revision rates: endplate subsidence (80.0%), device migration (77.8%), and structural fracture (63.8%). Failure modes showed distinct anatomical patterns, with migration predominating in the lumbar spine (31.4% vs. 2.3% cervical), while height loss occurred more frequently in cervical applications (20.5% vs. 7.8% lumbar). Among inserter issues, torque handle calibration failures (18.8%) and set screw complications (25.0%) accounted for nearly half of these events. Surgical technique was identified as the predominant contributing factor across all failure modes (28.7%), while inadequate fixation was specifically associated with device migration (35.6% of migration cases).
Conclusion: For surgeons, the high reported prevalence of inserter complications may be a key consideration for device selection, particularly regarding set screw mechanisms, despite the apparent lesser clinical impact. Similarly, heightened vigilance may be warranted for lumbar applications of expandable corpectomy cages due to increased migration risk.
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Source |
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http://dx.doi.org/10.1097/BRS.0000000000005492 | DOI Listing |