Interventional pain medicine · 2026
Adverse events associated with basivertebral nerve radiofrequency ablation: A comprehensive analysis from the MAUDE database.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
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.
Fischer Azadeh, Cooper Amanda N, McGuire Flynn, Ehsanian Reza, Glinka Pryzbysz Allison, McCormick Zachary L, Fogarty Alexandra E
Аннотация
BACKGROUND: Basivertebral nerve ablation (BVNA) is a minimally invasive intraosseous radiofrequency procedure for vertebrogenic chronic low back pain (CLBP). Although randomized controlled trials have established its efficacy, real-world safety data remain limited.
PURPOSE: Post-market adverse event (AE) characterization associated with BVNA using the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
STUDY DESIGN: Retrospective analysis of a national medical device adverse event database.
METHODS: The MAUDE database was queried for all reports involving FDA-cleared BVNA systems from inception to 2025. Reports were manually reviewed, deduplicated, and coded for AE type, severity, timing, and outcome. Frequencies were summarized with descriptive statistics.
RESULTS: A total of 96 unique medical device reports were analyzed. Vertebral compression fracture was the most frequently reported AE, occurring in 21.9% (21/96) of reports. Among the 21 VCF-containing reports, timing was documented in 12 (57.1%): 6 occurred within 30 days post-procedure (range: 4-21 days) and 6 occurred beyond 30 days (range: 33-294 days). Timing was not reported in the remaining 9 reports. An additional 2 reports described posterior element fractures and are reported separately (2.1%, 2/96). Other common AEs included increased low back pain (10.4%), superficial bleeding (2.1%), and emergency department visits (7.3%). Severe AEs were infrequent, including hospitalization (9.4%), retroperitoneal hematoma (7.3%), and death (2.1%). Both deaths were associated with anesthesia-related events rather than the BVNA device or procedure. No cases of infection, spinal/epidural hematoma, or major neurologic injury were identified. Most reports were manufacturer-submitted, with few voluntary reports or device returns.
CONCLUSIONS: This MAUDE-based review complements clinical trial data by characterizing the distribution of post-market adverse event reports associated with BVNA. Vertebral fracture was the most frequently reported event, with variable timing ranging from the day of the procedure to nearly 300 days post-BVNA; no consistent temporal pattern could be established. These findings do not permit conclusions about incidence or causality but identify vertebral fracture and pain as the most represented post-market signals, and highlight the need for prospective registries with standardized follow-up, pre-procedural bone health documentation, and detailed AE capture to more precisely define the long-term safety profile of BVNA.
PURPOSE: Post-market adverse event (AE) characterization associated with BVNA using the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
STUDY DESIGN: Retrospective analysis of a national medical device adverse event database.
METHODS: The MAUDE database was queried for all reports involving FDA-cleared BVNA systems from inception to 2025. Reports were manually reviewed, deduplicated, and coded for AE type, severity, timing, and outcome. Frequencies were summarized with descriptive statistics.
RESULTS: A total of 96 unique medical device reports were analyzed. Vertebral compression fracture was the most frequently reported AE, occurring in 21.9% (21/96) of reports. Among the 21 VCF-containing reports, timing was documented in 12 (57.1%): 6 occurred within 30 days post-procedure (range: 4-21 days) and 6 occurred beyond 30 days (range: 33-294 days). Timing was not reported in the remaining 9 reports. An additional 2 reports described posterior element fractures and are reported separately (2.1%, 2/96). Other common AEs included increased low back pain (10.4%), superficial bleeding (2.1%), and emergency department visits (7.3%). Severe AEs were infrequent, including hospitalization (9.4%), retroperitoneal hematoma (7.3%), and death (2.1%). Both deaths were associated with anesthesia-related events rather than the BVNA device or procedure. No cases of infection, spinal/epidural hematoma, or major neurologic injury were identified. Most reports were manufacturer-submitted, with few voluntary reports or device returns.
CONCLUSIONS: This MAUDE-based review complements clinical trial data by characterizing the distribution of post-market adverse event reports associated with BVNA. Vertebral fracture was the most frequently reported event, with variable timing ranging from the day of the procedure to nearly 300 days post-BVNA; no consistent temporal pattern could be established. These findings do not permit conclusions about incidence or causality but identify vertebral fracture and pain as the most represented post-market signals, and highlight the need for prospective registries with standardized follow-up, pre-procedural bone health documentation, and detailed AE capture to more precisely define the long-term safety profile of BVNA.