ArticleInternational journal of spine surgery2024
Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database.
Article in International journal of spine surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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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
4 citing papers in PubMed.
- Increasing adverse event reports coincide with declining Medicare billings for interspinous devices.North American Spine Society journal · 2026Article
- Standalone interspinous process devices for lumbar spinal stenosis: a critical literature review.BMC surgery · 2026Review
- Article
- Readmission rates and hospital charges: a comparative study of surgical interventions in degenerative spondylolisthesis and spinal canal stenosis.Journal of orthopaedic surgery and research · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInterspinous process devices (IPDs) introduce a new class of complications to surgical decompression without fusion: hardware-related complications. The purpose of this study was to describe the adverse events associated with IPDs. STUDY
designThis was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database.
methodsThe database was queried from its inception to November 2022 for reports associated with "Prosthesis, Spinous Process Spacer/Plate." Entries were categorized by event type, patient impact, and interventions.
resultsA total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%,
conclusionsThe most common adverse events were implant malfunction, inadequate efficacy, implant migration, and fracture. Concerningly, these complications require revision surgery in one-third of cases when they occur. Implant-specific assessments demonstrate a high prevalence of implant malfunctions for the Coflex and Superion implants. CLINICAL RELEVANCE: Interspinous process devices introduce a new class of complications to isolated spinal decompression surgery: implant-related complications. These complications occur both intraoperatively and postoperatively, and they frequently necessitate revision surgery. LEVEL OF EVIDENCE: 4:
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Registered trials
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