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Published on: May 11, 2020
An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for
Jack Filan1, Andrew Bowey2, Thomas Joyce3
1School of Medical Education, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK. J.Filan@nhs.net.
Background:
MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there have been several Field Safety Notices issued, including a worldwide product recall due to actuator endcap separation. We aimed to review adverse events reported to the Food and Drug Administration (FDA) regarding MAGEC rods, focusing on MAGEC X.
Methods:
Reports submitted to the Manufacturer and User Facility Device Experience database in relation to MAGEC devices were accessed and analysed using R Statistical Software. Exclusion criteria included duplicate and literature review reports (n = 54). Free-text data were analysed using inductive content analysis.
Results:
1016 adverse events were reported to 11/30/2023. 99.0% (1006) were submitted by the manufacturer. Reports primarily arose from the UK (465, 45.8%) or US (421, 41.4%). From free-text data the most frequent adverse events were distraction mechanism failure (573), device wear (272), and actuator seal damage (180). Rod fracture (n = 48) was not significantly associated with rod diameter (≤ 5.0 mm or > 5.0 mm), p = 0.736. 234 reports referenced MAGEC X devices; actuator endcap separation was identified in 41.9% (99). Other events include failure of distraction (63), surface damage (31), and rod fracture (15). On 06/30/2020 MAGEC X2 received FDA approval. Twenty reports reference devices manufactured after this date, seven describe distraction mechanism failure; notably there are no reports of endcap separation.
Conclusion:
These data represent the largest series of adverse events reported for MAGEC rods, including significant new data regarding MAGEC X. As well as endcap separation, failure of distraction, surface damage, and rod fracture were reported.
Insights
MAGnetic Expansion Control (MAGEC) rods, used for scoliosis, have reported adverse events including actuator endcap separation and distraction mechanism failure. Newer MAGEC X2 devices show no endcap separation reports.
Area of Science:
- Spinal surgery
- Medical device safety
- Pediatric orthopedics
Background:
- MAGnetic Expansion Control (MAGEC) rods are used to manage scoliosis, reducing the need for repeated surgical lengthening.
- Product recalls and Field Safety Notices have been issued for MAGEC rods, primarily due to actuator endcap separation.
- This study reviews adverse events associated with MAGEC rods, with a specific focus on the MAGEC X device.
Purpose of the Study:
- To analyze adverse events reported to the FDA concerning MAGEC rods.
- To investigate the types and frequencies of adverse events, particularly for the MAGEC X model.
Main Methods:
- Adverse event reports from the Manufacturer and User Facility Device Experience (MAUDE) database were analyzed.
- Data analysis included statistical methods and inductive content analysis of free-text fields.
- Reports submitted up to November 30, 2023, were included, with specific exclusions for duplicates and literature reviews.
Main Results:
- A total of 1016 adverse events were reported, predominantly by the manufacturer (99.0%).
- The most common adverse events were distraction mechanism failure (573), device wear (272), and actuator seal damage (180).
- For MAGEC X devices (234 reports), actuator endcap separation occurred in 41.9% (99), while newer MAGEC X2 devices (20 reports) had no reported endcap separations.
Conclusions:
- This analysis represents the largest series of reported adverse events for MAGEC rods, providing new insights into MAGEC X device issues.
- Key adverse events include actuator endcap separation, distraction mechanism failure, surface damage, and rod fracture.
- The absence of endcap separation reports for MAGEC X2 devices manufactured after FDA approval suggests potential design improvements.
