DOI 10.1097/brs.0000000000005492
Expandable, But at What Cost? Failure Patterns in Corpectomy Cages From 373 Real-World Adverse Events.
Аннотация
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.
MATERIALS AND
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, anatomic location, revision status, and contributing factors. χ 2 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 anatomic 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.
Предметные рубрики MeSH
Подготовка и перевод публикации
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Тип публикации указан по данным источника. Уровень доказательности автоматически не присваивается.