ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2025
Investigating complications of extreme lateral interbody fusion (XLIF) in the food and drug administration manufacturer and user facility device experience database.
Article in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Nutcracker phenomenon resulting in left gonadal vein dilation as a critical vascular consideration prior to lateral lumbar interbody fusion: illustrative case.Journal of neurosurgery. Case lessons · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe extreme lateral interbody fusion (XLIF) approach is being increasingly adopted to alleviate complications that are commonplace with other approaches; however, an analysis of the device malfunctions and patient injuries associated with the procedure was not available. The purpose of this study was to search the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE) for medical device reports (MDRs) associated with the XLIF procedure and categorically analyze the device and patient complications.
methodsMDRs from Jan. 2012 to Nov. 2022 from the MAUDE database regarding the XLIF procedure were filtered and analyzed by two independent reviewers. The complications associated with each MDR were then categorized into device malfunctions and patient injuries, further reclassified into intra-operative and post-operative complications, and analyzed for their relative frequencies.
resultsThe most common intra-operative device malfunction was the fracture of an instrument other than the interbody/cage at 8.1% (25/308) and the least common intra-operative device malfunction was an inability to insert the interbody/cage at 3.6% (11/308). The most common post-operative device malfunction was migration of something other than the cage at 5.2% (16/208) and the least common was cage migration at 2.3% (7/208). Post-operative wound issues were the most common patient injury at 7.3% (23/314) and the least common injuries included intra-operative paralysis and intra-operative death at 0.6% (2/314).
conclusionAlthough the XLIF procedure was developed to mitigate vascular injury, the predominant complication continues to be vascular injury, followed by organ injury based on MDRs submitted to the MAUDE database. This study provides an extensive search into the device malfunctions and patient injuries specific to the XLIF procedure, which has not been studied before. Such analysis provides a valuable focus for manufacturers and surgeons to improve patient safety by refining device design and optimizing surgical techniques.
Indexed as
Identifiers
40728664What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.