Class 2 Device Recall MAGEC 1 System

• Date Initiated by Firm: June 25, 2019
• Create Date: January 26, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0528-2022
• Recall Event ID: 89177
• 510(K)Number: K140178
• Product Classification: Growing rod system- magnetic actuation - Product Code PGN
• Product: MAGEC 1 System
• Code Information: All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.
• Recalling Firm/ Manufacturer: NuVasive Specialized Orthopedics, Inc.; 101 Enterprise Ste 100; Aliso Viejo CA 92656-2604
• For Additional Information Contact: Patrick Yrigoyen; 858-336-3421 Ext. 11
• Manufacturer Reason for Recall: Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
• FDA Determined Cause: Device Design
• Action: Beginning on 06/25/2019, a Field Safety Notice was communicated to all surgeon informing them that post-implantation fracture of an internal metallic component (i.e., locking pin) has been observed in early versions of the MAGEC System Rods that were manufactured prior to March 26, 2015. Fracture of the locking pin may affect the ability of the device to lengthen and may be associated with Titanium wear debris generation and localized tissue discoloration. Recommended User Actions: - NuVasive, Inc. voluntarily issues this Safety Alert to reinforce the Instructions for Use (IFU) of the MAGEC¿ System to clinical users - The IFU should be consulted on an ongoing basis throughout patient treatment with the MAGEC¿ System. - Users should follow the appropriate postoperative procedure to assess the MAGEC¿ System by X-ray imaging whenever the device is adjusted or at a minimum of once every six months. Typically, the device can be adequately visualized, and a fractured locking pin can be detected, on standard anteroposterior X-ray imaging. Figure 1 shows representative X-ray images for comparison of a device with an intact locking pin (A) to a device manufactured prior to March 26, 2015 with a fractured locking pin (B). A fractured locking pin can typically be identified by examining the noted areas to detect the separation of the internal components and/or the extension of an internal component beyond the device housing. - If a fractured locking pin is detected, removal of the device may be indicated. The decision to remove the device should be made by the physician in consultation with the patient and/or family. - If removal is deemed appropriate by the physician, the device and all associated accessories should be removed and the explanted device should be returned to NuVasive. - Clinical users should review the IFU and be aware of the warnings and precautions on an ongoing basis throughout patient treatment with the device. - Patients and/or families should be reminde
• Quantity in Commerce: 3,056 devices
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PGN and Original Applicant = ELLIPSE TECHNOLOGIES, INC.