MAGEC® Spinal Bracing and Distraction System RA002-4545SLRecalls & reported problems
Nuvasive Specialized Orthopedics, Inc. · Spinal bracing and distraction system, 4.5 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
Quick summary
This NuVasive MAGEC growing rod is an implant used to lengthen the spine over time. The 82 reports mostly describe rods that fail to lengthen, and some mention corrosion, sticking, or breakage. The reports include 31 injuries and no deaths. 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
- 82
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00856719002183), received between Jan 18, 2019 and Aug 5, 2024 — classified as 31 injuries, 51 malfunctions.
The most frequently reported specific device problem is “Defective Device” (34 reports).
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
Most reported problems
Device problems
- Defective Device34
- Corroded14
- Mechanical Jam14
- Failure to Advance11
- Break9
- Physical Resistance/Sticking9
- Mechanical Problem6
- Degraded5
Patient problems
- Failure of Implant67
- No Clinical Signs, Symptoms or Conditions9
- Metal Related Pathology4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Fluid Discharge1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2024Failure to Advance; Failure to Advance
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE THE ROD FAILING TO DISTRACT. AFTER THE ROD WAS REMOVED, THERE WAS VISIBLE METALLOSIS AND A LOOSE GASKET.
Patient problems: Failure of Implant; Metal Related Pathology
MAUDE report 19912150 ↗InjurySep 19, 2023Break; Break
INFORMATION WAS RECEIVED THAT AFTER THE FIRST DISTRACTION THE ROD WAS FOUND TO BE BROKEN VIA X-RAY. THE ROD HAS BEEN REMOVED AND REPLACED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17777043 ↗InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Metal Related Pathology
MAUDE report 17398734 ↗InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Metal Related Pathology
MAUDE report 17398317 ↗MalfunctionJul 11, 2023Failure to Advance; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17299079 ↗MalfunctionJun 16, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD WOULD NOT EXTEND AND FORCE TESTING WAS UNABLE TO BE COMPLETED. 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; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 17148912 ↗MalfunctionJun 16, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD WOULD NOT EXTEND AND FORCE TESTING WAS UNABLE TO BE COMPLETED. 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; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 17148908 ↗MalfunctionJun 16, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD WOULD NOT EXTEND AND FORCE TESTING WAS UNABLE TO BE COMPLETED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS CORROSION ON THE ROD. X-RAY OF THE ROD SHOWED METALLIC DEBRIS AROUND THE PIN AREA. 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 17148841 ↗MalfunctionJun 16, 2023Corroded; Corroded
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD EXERTED 33.4 LBF DURING FORCE TESTING. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS 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. 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 17144994 ↗MalfunctionMay 31, 2023Corroded; Mechanical Jam; 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 AS THE ELECTRONIC REMOTE CONTROLLER (ERC) WAS NOT FUNCTIONAL. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS CORROSION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 17034926 ↗MalfunctionMay 31, 2023Corroded; Mechanical Jam; 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 CORROSION AND GALLING. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO THE ROD NOT DISTRACTING AS THE PATIENT WAS OBESE. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 17033065 ↗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 DID NOT EXERT ANY FORCE DURING FORCE TESTING. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION. 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 17031787 ↗MalfunctionMay 26, 2023Mechanical Jam; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, FORCE TESTING WAS UNABLE TO BE PERFORMED. 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 17014592 ↗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. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO A BROKEN PIN AND HIGH ENERGY X-RAY EVALUATION REVEAL EVIDENCE OF A 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 17011794 ↗MalfunctionMay 26, 2023Corroded; Migration or Expulsion of Device; Mechanical Jam; Corroded; Migration or Expulsion of Device; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WOULD NOT EXTEND AND FORCE TESTING WAS UNABLE TO BE COMPLETED. 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 DUE TO DISTAL PULLOUT; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 17011291 ↗MalfunctionMay 26, 2023Break; Mechanical Jam; Break; Mechanical Jam
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17010683 ↗InjuryMay 25, 2023Mechanical Jam; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WOULD NOT EXTEND AND FORCE TESTING WAS UNABLE TO BE COMPLETED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING ON THE ROD. THE REASON FOR REMOVAL WAS DUE TO AN INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 17004461 ↗InjuryMar 9, 2023Break; Material Erosion; Break; Material Erosion
INFORMATION WAS RECEIVED THAT THERE WERE SIGNS OF METALLOSIS AND POSITIONING. THE ROD HAS BEEN EXPLANTED.
Patient problems: Metal Related Pathology
MAUDE report 16512690 ↗MalfunctionFeb 15, 2023Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WAS TESTED IN A JIG WITH AN EXTERNAL REMOTE CONTROLLER (ERC) AND IT EXERTED NO FORCE. ADDITIONALLY IT WAS FOUND THAT THE OUTER CASING, MAGNET AND EXTENDING BAR HAD SEIZED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 16381055 ↗MalfunctionFeb 15, 2023Structural Problem; Failure to Advance; Physical Resistance/Sticking; Structural Problem; Failure to Advance; Physical Resistance/Sticking
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION THE ROD EXERTED NO FORCE DURING TESTING. ADDITIONALLY, THE O-RING SEAL WAS BROKEN AND THE LEADSCREW WAS SEIZED INSIDE THE EXTENDING BAR. THE RADIAL BEARING WAS IN PLACE AND COULD ROTATE, HOWEVER, IT WAS SEIZED TO THE MAGNET. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 16379932 ↗MalfunctionFeb 15, 2023Failure to Advance; Material Protrusion/Extrusion; Physical Resistance/Sticking; Failure to Advance; Material Protrusion/Extrusion; Physical Resistance/Sticking
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD EXERTED NO FORCE DURING TESTING. ADDITIONALLY, THE INTERNAL COMPONENTS WERE SEIZED WITHIN THE OUTER CASING AND THE MAGNET WAS PROTRUDING FROM THE OUTER CASING. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 16379651 ↗MalfunctionFeb 10, 2023Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THE ROD EXERTED NO FORCE DURING FORCE TESTING. ADDITIONALLY, THE ROD WAS UNABLE TO BE FURTHER DISASSEMBLED AS IT WAS SEIZED TOGETHER AT THE OUTER CASING, MAGNET, AND EXTENDING BAR, THEREFORE, THE OTHER INTERNAL COMPONENTS WERE UNABLE TO BE EXAMINED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 16358652 ↗MalfunctionFeb 10, 2023Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THE ROD EXERTED NO FORCE DURING TESTING. ADDITIONALLY, THE EXTENDING BAR WAS REPORTED TO NOT BE PARALLEL WITH THE OUTER CASING AND FURTHER DISASSEMBLY WAS NOT POSSIBLE AS THE OUTER CASING, MAGNET, AND EXTENDING BAR WERE SEIZED.
Patient problems: Failure of Implant
MAUDE report 16356569 ↗MalfunctionFeb 10, 2023Degraded; Structural Problem; Failure to Advance; Physical Resistance/Sticking; Degraded; Structural Problem; Failure to Advance; Physical Resistance/Sticking
MalfunctionFeb 10, 2023Degraded; Structural Problem; Failure to Advance; Detachment of Device or Device Component; Degraded; Structural Problem; Failure to Advance; Detachment of Device or Device Component
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 RA002-5555SLRNuvasive 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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