An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods

Abstract

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.

Keywords: Early onset scoliosis; FDA; MAGEC; MAGEC X; MAUDE; Magnetically controlled growing rods.

Fig. 1

Photograph (top) and schematic (bottom) of changes to the actuator seal between MAGEC 1.3 (Panel A) and MAGEC X (Panel B) devices. Image source: Tognini et al., 2022.³ Reproduced under Creative Commons 4.0 without modification

Fig. 2

Bar chart representing the number of reports submitted per year. No missing data. 2023 data to 11/30/2023

Fig. 3

Sunburst plot of MAGEC rod diameter (inner ring) and actuator length (outer ring). Values represent the number of reports in each category, with data visualised hierarchically. Unknown or missing values excluded

Fig. 4

Pie chart representing frequency of Device Problem Codes, total 1393 codes. Codes utilising similar terminology combined. Codes with less than 30 events excluded

Fig. 5

Sunburst plot of mechanical failure mechanism described by inductive content analysis. Inner ring describes major themes, with subcodes represented in the outer ring. No missing data

Fig. 6

Notable manufacturer narrative repeated verbatim in at least ten reports of actuator endcap separation. Quoted from report number 11092282. Key statements highlighted in bold. FSCA – field safety corrective action