The NuVasive MAGEC Rod Urgent Field Safety Notice Concerning Locking Pin Fracture: How Does Data From an Independent Explant Center Compare?

Spine
Thomas J JoyceMichael J Gibson

Abstract

Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods. The aim of this study was to quantify the rate of locking pin breakage in explanted MAGEC rods and compare with the manufacturer's data. On June 25, 2019, NuVasive released an Urgent Field Safety Notice stating that MAGEC rods manufactured before March 26, 2015 had a higher than expected locking pin breakage rate of 5%. For rods made on or after that date, no pin breakages had occurred. From our independent explant database of 139 explanted MAGEC rods supplied from 10 UK spinal centers (Belfast, Bristol, Birmingham, Edinburgh, Exeter, Leeds, Newcastle, Nottingham, Oxford, and Sheffield) and one Danish center (Aarhus), we divided the rods into those manufactured before March 26, 2015, and those manufactured on or after that date. MAGEC rods were cut open to fully assess internal components including locking pins. From each of the two cohorts, 10 locking pins were selected at random and their diameters were measured using a micrometer. One hundred and five explanted MAGEC rods were made before March 26, 2015 and could be disassembled to allow the locking pin to be examined. Fifty-nine percent (62/105) of these locking pins had fractured. For the MAGEC rods man...Continue Reading

References

Dec 29, 2015·The Spine Journal : Official Journal of the North American Spine Society·Conor S JonesMichael Hutton
Dec 31, 2015·Journal of Orthopaedic Surgery·Jason Pui Yin CheungKenneth M C Cheung
Feb 5, 2016·The Spine Journal : Official Journal of the North American Spine Society·Kar H TeohSashin Ahuja
Jan 20, 2017·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·Vasiliki C PanagiotopoulouAlister J Hart
Jul 26, 2018·Spine·Paul R P RushtonThomas J Joyce

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