BEUDAMED
    FDA Recall Open, Classified

    MAGEC 1 System

    Recall: Z-0528-2022 · Initiated June 25, 2019

    Recall

    Recall Number
    Z-0528-2022
    Event Number
    89177
    Firm
    NuVasive Specialized Orthopedics, Inc.
    FEI Number
    3006179046
    Product Code
    PGN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 25, 2019
    Address
    101 Enterprise, Ste 100, Aliso Viejo, CA, 92656-2604

    Description

    MAGEC 1 System

    Reason

    Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

    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

    Distribution

    Worldwide

    Quantity

    3,056 devices