MAGEC MC2-5090SRecalls & reported problems
Nuvasive, Inc. · MAGEC 2 Rod, 5.0mm 90mm Standard · Class 2 · Implant
All models of MAGEC (4)
Data updated Oct 16, 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 2 growing rod is a magnetically actuated spinal rod that lengthens a child's spine without repeat surgery. The 33 reports mostly describe rods that would not lengthen, corroded or worn surfaces, and locking pin fractures, with several rods removed or revised after failing to distract; 4 reports involve injuries and no deaths. One open recall, started April 2025, covers a lot assembled with a 5.5mm rod instead of the required 5.0mm.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00887517834041), received between Nov 5, 2018 and Feb 29, 2024 — classified as 4 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (8 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K171791); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Recalls naming this device
- Apr 3, 2025Open, Classified
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
Z-1657-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Mechanical Problem8
- Corroded6
- Migration or Expulsion of Device6
- Migration5
- Fracture4
- Defective Device3
- Mechanical Jam3
- Failure to Advance2
Patient problems
- Failure of Implant29
- No Clinical Signs, Symptoms or Conditions7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 29, 2024Failure to Advance; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18807776 ↗MalfunctionFeb 29, 2024Failure to Advance; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18807744 ↗InjuryJun 16, 2023Corroded; Mechanical Jam; Corroded; 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 FUNCTIONING. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION ON THE ROD. IT WAS REPORTED THAT THE ROD WAS REMOVED AS PART OF A PLANNED REMOVAL PROCEDURE AFTER DESIRED LENGTHENING HAD BEEN ACHIEVED AS WELL AS THE PATIENT EXPERIENCING PAIN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant; Pain
MAUDE report 17148894 ↗MalfunctionMay 31, 2023Break; Corroded; Fracture; Mechanical Jam; Break; Corroded; Fracture; 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 AS THE ELECTRONIC REMOTE CONTROLLER (ERC) WAS NOT FUNCTIONAL. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS CORROSION. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO A LOCKING PIN FRACTURE. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 17032141 ↗MalfunctionMay 25, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD WAS REMOVED DUE TO THE PATIENT NOT COMPLYING WITH DISTRACTION. FORCE TESTING WAS UNABLE TO BE COMPLETED AS THE ROD WOULD NOT EXTEND. IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION ON THE ROD. UPON DISASSEMBLY, THE ROD WAS FOUND TO HAVE SOME METALLIC CORROSION AROUND THE MAGNET AREA. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17004230 ↗MalfunctionJun 22, 2022Corroded; Naturally Worn; Corroded; Naturally Worn
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND WEAR AND OTHER SURFACE DAMAGE. IT WAS REPORTED THAT THE ROD WAS REMOVED AS PART OF A PLANNED REMOVAL PROCEDURE AFTER THE ROD HAD FULLY EXTENDED; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 14779886 ↗InjuryJun 8, 2022Mechanical Problem; Naturally Worn; Scratched Material; Mechanical Problem; Naturally Worn; Scratched Material
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD FAILING TO DISTRACT. DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THE ROD UNABLE TO DISTRACT. ADDITIONALLY, DISCOLORATION, WEAR, SCRATCHES, AND OTHER SURFACE DAMAGE WAS NOTED. THERE WAS NO FURTHER REPORTED PATIENT IMPACT AND NO PATIENT OR USER INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 14629745 ↗MalfunctionApr 13, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD WOULD NOT DISTRACT. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14104387 ↗MalfunctionMar 29, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. AS PER THE REPORTER, THE ROD HAD AN END CAP FAILURE. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13938678 ↗MalfunctionJan 6, 2022Fracture; Mechanical Problem; Fracture; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD DID NOT FULLY ACHIEVE THE DESIRED DISTRACTION INCREMENTS DURING LENGTHENING SESSIONS. X-RAYS REVEALED THE RIGHT ROD HAD A MAGNET FRACTURE AND A BROKEN PIN. THE DEVICE WAS REMOVED FOR FINAL FUSION. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS ORGANIC MATTER BUILDUP AROUND THE ROD AND TISSUE DISCOLORATION. NO PATIENT ADVERSE REACTION OR IMPACT WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 13182298 ↗MalfunctionJan 6, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD DID NOT FULLY ACHIEVE THE DESIRED DISTRACTION INCREMENTS DURING LENGTHENING SESSIONS. THE DEVICE WAS REMOVED FOR FINAL FUSION. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS ORGANIC MATTER BUILDUP AROUND THE ROD AND TISSUE DISCOLORATION. NO PATIENT ADVERSE REACTION OR IMPACT WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 13182236 ↗MalfunctionNov 8, 2021Mechanical Problem; Mechanical Problem
MalfunctionNov 3, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
MalfunctionOct 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION WAS RECEIVED THAT THE ROD'S END CAP DISENGAGED. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12584561 ↗MalfunctionSep 20, 2021Fracture; Fracture
INFORMATION WAS RECEIVED THAT THE ROD WAS FRACTURED. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12497740 ↗MalfunctionAug 12, 2021Corroded; Corroded
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 12315816 ↗MalfunctionAug 12, 2021Corroded; Corroded
INFORMATION WAS RECEIVED THAT A REVISION WAS PERFORMED FOR A FINAL FUSION. AS PER THE REPORTER, UPON EXPLANT THE ROD WAS NOTED TO HAVE CORROSION AND THERE WAS METAL WEAR DEBRIS IN THE TISSUE. NO PATIENT HARM WAS REPORTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 12315505 ↗MalfunctionApr 5, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration
NO NEW INFORMATION PROVIDED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 11615120 ↗MalfunctionApr 5, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration
NO NEW INFORMATION PROVIDED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 11615119 ↗InjuryMar 1, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE END-CAP WAS SEPARATED.
Patient problems: Failure of Implant
MAUDE report 11397121 ↗MalfunctionMar 1, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE ROD WAS NOT LENGTHENING. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THERE WAS NO DEVICE PROBLEM.
Patient problems: Failure of Implant
MAUDE report 11397093 ↗MalfunctionDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO AN INFECTION. THERE WAS NO PATIENT INJURY REPORTED. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) THE ROD FUNCTIONED AS INTENDED.
Patient problems: Unspecified Infection
MAUDE report 11098828 ↗MalfunctionDec 28, 2020Unstable; Unstable
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON AN (B)(6) 2019. AS PER THE REPORTER THE ROD PULLED OUT. THERE WAS NO PATIENT INJURY REPORTED. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) THE ROD FUNCTIONED AS INTENDED.
Patient problems: Failure of Implant
MAUDE report 11085371 ↗MalfunctionNov 20, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT X-RAY IMAGES REVEALED THAT THE END CAP HAD DISENGAGED. NO REVISION PROCEDURE HAS BEEN SCHEDULED AT THIS TIME. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10880798 ↗MalfunctionAug 15, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
ADDITIONAL INFORMATION PROVIDED: H2, H3, H6, H10.
Patient problems: Failure of Implant
MAUDE report 10411801 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171791. One submission often covers many models, so check the product and lot details in each record.
- Z-1898-2020 · Feb 13, 2020 · TerminatedNUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVa
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® 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 MC2-5590SNuvasive Specialized Orthopedics, Inc. · Growing Rod System- Magnetic Actuation1 recall26 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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