MAGEC MC2-5070SRecalls & reported problems
Nuvasive, Inc. · MAGEC 2 Rod, 5.0mm 70mm Standard · Class 2 · Implant
Quick summary
This NuVasive MAGEC rod is an implanted magnetically adjustable growing rod used to straighten children's spines. There are 23 adverse event reports naming this device, with 8 injuries and no deaths. Reports mostly describe rods breaking, bending, shifting position, or failing to lengthen; one mentions signs of metallosis and the rod being removed. No recalls name this device.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00887517834027), received between Sep 4, 2019 and May 31, 2023 — classified as 8 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Break” (6 reports).
2 other recalls 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break6
- Defective Device4
- Migration3
- Corroded2
- Defective Component2
- Failure to Advance2
- Mechanical Problem2
- Migration or Expulsion of Device2
Patient problems
- Failure of Implant20
- Fall1
- Metal Related Pathology1
- No Clinical Signs, Symptoms or Conditions1
- Seizures1
- Unspecified Infection1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2023Break; Corroded; Physical Resistance/Sticking; Break; Corroded; Physical Resistance/Sticking
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17032425 ↗MalfunctionMay 26, 2023Break; Corroded; Mechanical Jam; Break; Corroded; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, FORCE TESTING WAS UNABLE TO BE PERFORMED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION. HIGH ENERGY X-RAY EVALUATION SHOWED EVIDENCE OF INTERNAL SCREW 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 17014994 ↗MalfunctionMay 9, 2023Break; Break
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16898066 ↗MalfunctionMay 9, 2023Failure to Advance; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16897881 ↗InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED THAT THERE WERE SIGNS OF METALLOSIS. THE ROD HAS BEEN EXPLANTED AND REPLACED WITH A TRADITIONAL GROWING ROD. REPORT 1 OF 2.
Patient problems: Metal Related Pathology
MAUDE report 15259529 ↗MalfunctionFeb 2, 2022Material Twisted/Bent; Material Twisted/Bent
INFORMATION WAS RECEIVED THAT THE ROD DID NOT GET MUCH DISTRACTION AS IT WAS FOUND TO BE SEVERELY BENT. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13424265 ↗MalfunctionFeb 2, 2022Break; Break
INFORMATION WAS RECEIVED THAT THE ROD DID NOT GET MUCH DISTRACTION AS IT WAS FOUND TO BE BROKEN. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13424216 ↗MalfunctionJul 13, 2021Mechanical Problem; Mechanical Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 12161227 ↗MalfunctionJun 23, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
InjuryApr 28, 2021Break; Break
MalfunctionMar 11, 2021Mechanical Problem; Failure to Advance; Mechanical Problem; Failure to Advance
ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 11465462 ↗MalfunctionMar 1, 2021Unstable; Unstable
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO PULLOUT. DURING A REVIEW OF THE INVESTIGATION FINDINGS FROM (B)(4) THERE WAS NO PROBLEM FOUND.
Patient problems: Failure of Implant
MAUDE report 11397109 ↗MalfunctionJan 5, 2021Fracture; Fracture
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED (B)(6) 2020. AS PER THE REPORTER THE ROD WAS FRACTURED. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD WAS WORKING AND POSSIBLE TO BE DETRACTED, BUT NOT CONFORM TO THE FORCE TEST.
Patient problems: Failure of Implant
MAUDE report 11115059 ↗MalfunctionJan 4, 2021Unstable; Unstable
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON AN (B)(6) 2020. 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 11115047 ↗MalfunctionDec 9, 2020Break; Break
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. AS PER THE REPORTER, THE ROD WAS BROKEN. REPORTEDLY, WHEN THE ROD WAS EXPLANTED IT WAS NOTICEABLY BROKEN AT THE PART WHERE THE ROD COMES OUT WHEN DISTRACTING. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10979216 ↗InjuryJul 17, 2020Defective Component; Migration; Defective Component; Migration
INFORMATION WAS RECEIVED THAT A PATIENT UNDERWENT A REVISION PROCEDURE UNRELATED TO A PRODUCT MALFUNCTION. DURING A DISTRACTION ON (B)(6) 2020 THEY NOTICED A DETACHMENT OF THE ACTUATOR END CAP.
Patient problems: Failure of Implant
MAUDE report 10292753 ↗MalfunctionJul 17, 2020Defective Component; Migration; Defective Component; Migration
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, X-RAY IMAGES REVEALED THAT THE END CAP HAD DISENGAGED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10292225 ↗InjuryJun 3, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER REPORTER THE PATIENT WAS EXPERIENCING POSTOPERATIVE INFECTION, FEVER, AND SWELLING.
Patient problems: Failure of Implant
MAUDE report 10117306 ↗InjuryApr 27, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. BASED ON ENGINEERING REVIEW PERFORMED ON (B)(6) 2020, IT WAS IDENTIFIED THAT THE ROD FAILED TO DISTRACT.
Patient problems: Failure of Implant
MAUDE report 10002135 ↗InjuryMar 13, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER THE REPORTER, THE ROD WAS REMOVED DUE TO INFECTION. IMPLANTATION DATE: (B)(6) 2019, DATE OF REVISION: (B)(6) 2019.
Patient problems: Unspecified Infection
MAUDE report 9831501 ↗MalfunctionMar 3, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT THE END CAP DISLODGED FROM THE ROD. AS PER REPORTER PHYSICIAN DECIDED TO CONTINUE WITH DISTRACTIONS. NO REVISION PROCEDURE IS PLANNED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 9783277 ↗InjuryFeb 12, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WILL BE PERFORMED (B)(6) 2020. AS PER REPORTER, THE PATIENT HAD A SEIZURE AND FELL OFF THE COUCH. IT WAS NOTICED DURING FINAL LENGTHENING THAT THE END CAP HAD DISENGAGED FROM THE ROD.
Patient problems: Fall; Seizures
MAUDE report 9699748 ↗InjurySep 4, 2019Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT ALLEGED THE MAGEC RODS WERE NO LONGER DISTRACTING. AS PER REPORTER, ONCE RADIOGRAPHS WERE TAKEN, IT REVEALED A DAMAGED PIN ON ONE OF THE RODS. ON (B)(6) 2019 A REVISION PROCEDURE WAS PERFORMED.
Patient problems: Failure of Implant
MAUDE report 8962026 ↗
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-1657-2025 · Apr 3, 2025 · Open, ClassifiedMAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
- 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 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 MC2-5590SNuvasive 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.