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

• Published in: Spine (Philadelphia, Pa. 1976) Pa. 1976), 2020-07, Vol.45 (13), p.872-876
• Main Authors: Joyce, Thomas J., Smith, Simon L., Kandemir, Goksu, Rushton, Paul R. P., Fender, David, Bowey, Andrew J., Gibson, Michael J.
• Format: Article
• Language: English
• Subjects: Adolescent; Child; Child, Preschool; Databases, Factual; Device Removal; Female; Humans; Male; Manufacturing Industry - statistics & numerical data; Orthopedic Fixation Devices - adverse effects; Orthopedic Fixation Devices - statistics & numerical data; Prostheses and Implants - adverse effects; Prostheses and Implants - statistics & numerical data; Prosthesis Failure; Scoliosis - surgery
• ISSN: 0362-2436; 1528-1159
• DOI: 10.1097/BRS.0000000000003439

STUDY DESIGN.Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods. OBJECTIVE.The aim of this study was to quantify the rate of locking pin breakage in explanted MAGEC rods and compare with the manufacturerʼs data. SUMMARY OF BACKGROUND 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. METHODS.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. RESULTS.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 manufactured on or after March 26, 2015, 21% (6/29) were found to have fractured locking pins. Locking pins in MAGEC rods made on or after March 26, 2015 were of a stronger material and a larger diameter. CONCLUSION.Fifty-nine percent of the locking pins in MAGEC rods manufactured before March 26, 2015 had fractured, far greater than the 5% stated in the Urgent Field Safety Notice. Locking pin fracture still occurred in MAGEC rods manufactured on or after that date, in 21% of cases. This contrasted with the 0% reported by the manufacturer.Level of Evidence4