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MAGEC® Spinal Bracing and Distraction System MC2-5570RRecalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · Spinal bracing and distraction system, 5.5 mm offset rod with 70 mm actuator · Class 2

All models of MAGEC Spinal Bracing and Distraction System (29)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812258022655), received between Jul 9, 2021 and May 31, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Nov 1, 2022Class IIOpen, Classified

    During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.

    Z-0559-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Corroded1
  • Mechanical Jam1
  • Mechanical Problem1
  • No Apparent Adverse Event1

Patient problems

  • Failure of Implant2
  • Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 31, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam

    AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WOULD NOT DISTRACT AND FORCE TESTING WAS UNABLE TO BE PERFORMED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS CORROSION AND GALLING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Failure of Implant

    MAUDE report 17034318 ↗
  • MalfunctionSep 15, 2021Mechanical Problem; Mechanical Problem

    NO ADDITIONAL INFORMATION PROVIDED.

    Patient problems: Failure of Implant

    MAUDE report 12477918 ↗
  • MalfunctionJul 9, 2021No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED FOR A FINAL FUSION. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD EVIDENCE OF GALLING.

    Patient problems: Insufficient Information

    MAUDE report 12144539 ↗

Other Growing Rod System- Magnetic Actuation devices

All Growing Rod System- Magnetic Actuation devices →

Sources and updates

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