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On February 13, 2020, NuVasive Inc. issued a voluntary recall of the MAGEC X magnetically controlled growing rod device (most recent model of MAGEC implants). The actuator end cap was noted to separate from the lengthening apparatus in approximately 0.5% of devices implanted. When this end cap dislodges from the lengthening mechanism, the internal threads become exposed to body fluids and may lead to extravasation of metallic wear debris. Because they could not determine the root cause of the end cap failure as a manufacturing or design issue, the MAGEC X devices were pulled off the market by NuVasive to further investigate and address the root cause of the issue. This is a class II FDA recall that pulls the device from the market for new implantation into patients. This recall does not pertain to the prior MAGEC rod model known as MAGEC 1.5. The recall is not limited to the US.
The Scoliosis Research Society is invested in guiding our member surgeons to make the best decisions for ensuring patient safety. The Presidential Line approved the formation of this FAQ to help clear up misconceptions and to guide decision making during this recall. As this situation is evolving, this FAQ will also evolve.
What does the end cap separation look like?
The end cap separation is best seen on an AP X-ray and is demonstrated as below (image courtesy of NuVasive):
Can I see this separation on an ultrasound image?
As above, it is possible that this separation might be visible on an ultrasound image but it is unclear if partial separations or significantly displaced separations would be visible. The best image to visualize this is an AP X-ray. The SRS recommends getting a single AP X-ray to confirm end cap integrity.
How do I know which patients have the MAGEC X device implanted versus MAGEC 1.5 or other prior generations?
Your NuVasive distributor can run a report of any implanted MAGEC X devices with dates of implantation that can help you identify which patients may be affected.
Will NuVasive contact patients and families who have MAGEC X devices implanted?
No. NuVasive does not possess the contact information of any patient who has received this device. It is up to the surgeon to discuss this issue with each of their patients and families who have this device to notify them of this issue.
Should I remove this device from my patient who currently has this device implanted?
At this time, NuVasive does not recommend removing MAGEC X implants from patients who currently have these implants and show no radiographic evidence of end cap failure. Because the failure rate is so low (0.5%), the risk of rod revision outweighs the risk of end cap failure. As always, a surgeon’s clinical judgment should dictate treatment.
What implants are available if I need to implant a new magnetically controlled growing rod?
NuVasive has a small inventory of MAGEC 1.5 devices that can be used on a case by case basis for urgent or emergent cases. The devices will be preferentially allocated to patients who have rod/anchor failure or other emergent issues. At this time, NuVasive recommends delaying new implantations until at least May 1, 2020, by which time they will have the ability to restock inventory for MAGEC 1.5 to meet demand. Of note, the MAGEC 1.5 rods only come in 4.5 and 5.5 diameters. If the anchors do not fit (i.e. VEPTR anchors), other fixation solutions may be necessary.
Help! My patient’s MAGEC X rod has this end cap separation. What do I do?
First determine if it is still lengthening appropriately. If so, have a discussion with the family regarding the situation and use your clinical judgement regarding maintaining or exchanging the implants. If an exchange is judged to be appropriate clinically (concern of wear debris or the device is not functioning), contact NuVasive to secure inventory for replacement. A MAGEC 1.5 device can be used to replace this rod. Three rods will be made available at the time of surgery: two standard rods and one offset rod.
Will NuVasive provide for any rods that need to be replaced because of this recall?
Yes, rods will be replaced free of charge. However, other hospital costs are not included at this time. NuVasive has pledged to work on a case by case basis if necessary as to not cause undue financial hardship on families affected by this recall.
My patients are still lengthening on ultrasound and thus cannot have this end cap separation, right?
No, the device can still lengthen even if the end cap has separated. The concern is that with the actuator internal mechanism exposed to body fluids, there may be extravasation of wear debris into local tissues. This is colloquially known as metallosis.
Is there any known risk of metallosis?
There is no known immediate, documented clinical risks to MAGEC patients solely from metallosis.
What materials are present in the wear debris?
On analysis, most of the wear debris appears to be titanium.
What is a Class II FDA recall?
Recalls are classified into a numerical designation (I, II, or III) by the FDA to indicate the relative degree of health hazard presented by the product being recalled.
Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
How can I contact the company about this?
Contact your local sales team or email firstname.lastname@example.org.
Yilgor C, Efendiyev A, Akbiyik F, Demirkiran G, Senkoylu A, Alanay A, Yazici M. Metal Ion Release During Growth-Friendly Instrumentation for Early-Onset Scoliosis: A Preliminary Study. Spine Deform. 2018 Jan;6(1):48-53. doi: 10.1016/j.jspd.2017.06.005. Epub 2018 Dec 30. PubMed PMID: 31994123.
Li Y, Graham CK, Robbins C, Caird MS, Farley FA. Elevated Serum Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-friendly Instrumentation. J Pediatr Orthop. 2019 Nov 1. doi: 10.1097/BPO.0000000000001463. [Epub ahead of print] PubMed PMID: 31688816.