MAGEC® Spinal Bracing and Distraction System MC2-5590SRecalls & reported problems
Nuvasive Specialized Orthopedics, Inc. · Spinal bracing and distraction system, 5.5 mm standard rod with 90 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.
Quick summary
This NuVasive MAGEC spinal rod is a growing rod implanted to help the spine grow and straighten. The 26 reports mostly describe rods failing to lengthen, end caps working loose, or parts shifting, sometimes needing removal or revision surgery. There are no deaths and 5 injuries. One open recall, started November 2022, covers a problem where the sterile packaging barrier could fail, leaving the device non-sterile.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00812258022662), received between Sep 25, 2019 and Oct 23, 2024 — classified as 5 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Migration” (7 reports).
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.
Reports received per month
Recalls naming this device
- 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
- Migration7
- Failure to Advance4
- Mechanical Problem4
- Migration or Expulsion of Device4
- Corroded2
- Degraded2
- Detachment of Device or Device Component2
- Fracture2
Patient problems
- Failure of Implant20
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Failure to Advance; Failure to Advance
INFORMATION WAS RECEIVED THAT ONE OF THE IMPLANTED RODS FAILED TO LENGTHEN SO BOTH RODS WERE REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 20517467 ↗InjuryOct 23, 2024Failure to Advance; Failure to Advance
INFORMATION WAS RECEIVED THAT ONE OF THE IMPLANTED RODS FAILED TO LENGTHEN SO BOTH RODS WERE REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 20516591 ↗InjuryAug 14, 2024Break; Failure to Advance; Break; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19982049 ↗MalfunctionJun 16, 2023Mechanical Jam; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT FORCE TESTING WAS UNABLE TO BE COMPLETED DUE TO THE EXTERNAL REMOTE CONTROLLER (ERC) NOT BEING FUNCTIONAL. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING ON THE ROD. IT WAS REPORTED THAT THE ROD WAS REMOVED AS PART OF A PLANNED REMOVAL PROCEDURE AFTER DESIRED LENGTHENING HAD BEEN ACHIEVED; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 17148921 ↗MalfunctionJul 19, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE OCCURRED DUE TO THE END CAP POPPING OFF AND THE ROD NO LONGER WORKING. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 15055723 ↗MalfunctionMar 17, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD COULD NOT BE DISTRACTED ANYMORE DUE TO THE END CAP LOOSENING OF ACTUATOR. THE ROD WAS EXPLANTED AND A FUSION TOOK PLACE FROM T2-L4. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13791897 ↗MalfunctionMar 17, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD COULD NOT BE DISTRACTED ANYMORE DUE TO THE END CAP LOOSENING OF THE ACTUATOR. THE ROD WAS EXPLANTED AND A FUSION TOOK PLACE FROM T2-L4. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13791432 ↗MalfunctionSep 24, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT THE END CAP CAME OFF AND THE ROD WAS UNABLE TO DISTRACT. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12528369 ↗MalfunctionSep 9, 2021Corroded; Fracture; Corroded; Fracture
MalfunctionSep 2, 2021Degraded; Degraded
INFORMATION WAS RECEIVED THAT THE ROD PRESENTS WITH FRETTING. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12417156 ↗MalfunctionSep 2, 2021Degraded; Degraded
MalfunctionJul 13, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT WHILE USING ULTRA-SOUND TO MEASURE DISTRACTION LENGTH, A LARGER MEASUREMENT WAS RECORDED THAN WAS PROGRAMMED. THE SURGEON REQUESTED ANOTHER X-RAY AND UPON REVIEW, IT WAS NOTED THAT THE ENDCAP HAD SEPARATED FROM THE ACTUATOR. NO PATIENT HARM WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12159411 ↗MalfunctionJul 13, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT WHILE USING ULTRA-SOUND TO MEASURE DISTRACTION LENGTH, A LARGER MEASUREMENT WAS RECORDED THAN WHAT WAS PROGRAMMED. THE SURGEON REQUESTED ANOTHER X-RAY AND UPON REVIEW, THE ENDCAP WAS NOTED TO BE SEPARATED FROM THE ACTUATOR. NO PATIENT HARM WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12159355 ↗MalfunctionJul 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD EVIDENCE OF GALLING.
Patient problems: Insufficient Information
MAUDE report 12144726 ↗MalfunctionApr 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION WAS RECEIVED THAT THE ROD ENDCAP WAS FOUND TO BE SEPARATED; HOWEVER, THE ROD ACHIEVED ITS INTENDED LENGTH AND THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641243 ↗MalfunctionApr 9, 2021Fracture; Fracture
INFORMATION WAS RECEIVED THAT DURING AN EXPLANT PROCEDURE FOR FINAL FUSION AFTER THE ROD HAD ACHIEVED ITS INTENDED PURPOSE, IT WAS NOTED THERE WAS A FRACTURE THROUGH THE ROD END CAP. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641238 ↗MalfunctionNov 3, 2020Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD WAS NOT LENGTHENING. THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF THE PATIENT WILL HAVE A REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 10782789 ↗MalfunctionNov 3, 2020Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD WAS NOT LENGTHENING. THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF THE PATIENT WILL HAVE A REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 10782786 ↗MalfunctionOct 30, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT ULTRASOUND IMAGES REVEALED THAT THE END CAP HAD MIGRATED. IT IS UNKNOWN IF A REVISION PROCEDURE IS PLANNED AT THIS TIME. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10766472 ↗MalfunctionJun 2, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT X-RAY IMAGES REVEALED THAT THE END CAP HAD DISENGAGED. AT THIS TIME IT IS UNKNOWN IF A REVISION PROCEDURE IS PLANNED. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10112897 ↗MalfunctionApr 27, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT X-RAY IMAGING REVEALED THAT THE END CAP HAD DISENGAGED. AS PER THE SURGEON, THE RODS WILL REMAIN IMPLANTED UNTIL DEFINITIVE FUSION.
Patient problems: Failure of Implant
MAUDE report 10003644 ↗MalfunctionMar 16, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT THE END CAP WAS DISENGAGED FROM THE ROD. THE SURGEON HAS NEVER ATTEMPTED ANY DISTRACTIONS.
Patient problems: Failure of Implant
MAUDE report 9837641 ↗MalfunctionMar 3, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT THE END CAP HAD DISLODGED FROM THE ROD. AT THIS TIME IS UNKNOWN IF PATIENT WILL UNDERGO A REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 9783264 ↗InjuryFeb 27, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE PATIENT WAS BEING TREATED FOR INFLAMMATION AND X-RAYS REVEALED THAT BOTH END CAPS HAD DISLODGED FROM THE RODS.
Patient problems: Failure of Implant
MAUDE report 9766211 ↗MalfunctionFeb 27, 2020Corroded; Structural Problem; Failure to Advance; Detachment of Device or Device Component; Migration; Physical Resistance/Sticking; Corroded; Structural Problem; Failure to Advance; Detachment of Device or Device Component; Migration; Physical Resistance/Sticking
INFORMATION WAS RECEIVED THAT X-RAY IMAGES REVEALED THAT THE END CAP HAD DISENGAGED FROM THE ROD. IT IS UNKNOWN IF A REVISION PROCEDURE IS PLANNED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 9765878 ↗
Other Growing Rod System- Magnetic Actuation devices
- MAGEC® Spinal Bracing and Distraction System RA002-5555SLNuvasive Specialized Orthopedics, Inc. · Growing Rod System- Magnetic Actuation112 reports
- MAGEC MC2-5090SNuvasive, Inc. · Growing rod system- magnetic actuation1 recall33 reports
- MAGEC® Spinal Bracing and Distraction System RA002-4545SLNuvasive Specialized Orthopedics, Inc. · Growing Rod System- Magnetic Actuation82 reports
- MAGEC® Spinal Bracing and Distraction System RA002-5555SLRNuvasive Specialized Orthopedics, Inc. · Growing Rod System- Magnetic Actuation81 reports
- MAGEC® Spinal Bracing and Distraction System MC2-4590SNuvasive Specialized Orthopedics, Inc. · Growing Rod System- Magnetic Actuation1 recall25 reports
- MAGEC® Spinal Bracing and Distraction System MC2-4570SNuvasive Specialized Orthopedics, Inc. · Growing Rod System- Magnetic Actuation1 recall14 reports
- MAGEC® Spinal Bracing and Distraction System MC2-5570SNuvasive Specialized Orthopedics, Inc. · Growing Rod System- Magnetic Actuation1 recall14 reports
- MAGEC® Spinal Bracing and Distraction System MC2-5590RNuvasive Specialized Orthopedics, Inc. · Growing Rod System- Magnetic Actuation1 recall11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page