MAGEC® Spinal Bracing and Distraction System MS1-4590SRecalls & 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 a magnetic, remotely adjustable spinal rod used to lengthen the spine as a child grows. The 30 reports mostly describe the rod failing to lengthen, breaking, or jamming, with several patients needing revision surgery and metal debris found on removal; 14 reports involved injuries and no deaths were reported. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00812258026295), received between Apr 9, 2019 and May 1, 2024 — classified as 14 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Defective Device” (10 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 Device10
- Fracture6
- Mechanical Jam5
- Mechanical Problem5
- Break3
- Failure to Advance3
- Appropriate Device Problem Term/Code Not Available2
- Material Erosion2
Patient problems
- Failure of Implant29
- No Known Impact Or Consequence To Patient3
- Metal Related Pathology2
- Foreign Body Reaction1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2024Material Erosion; Failure to Advance; Material Erosion; Failure to Advance
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD NOT DISTRACTING. DURING THE REMOVAL PROCEDURE THERE WAS METAL DEBRIS NOTED AT THE SUPERIOR ASPECT OF THE LENGTHENING SEGMENT.
Patient problems: Failure of Implant; Metal Related Pathology
MAUDE report 19222196 ↗InjuryMay 1, 2024Material Erosion; Failure to Advance; Material Erosion; Failure to Advance
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD NOT DISTRACTING. DURING THE REMOVAL PROCEDURE THERE WAS METAL DEBRIS NOTED AT THE SUPERIOR ASPECT OF THE LENGTHENING SEGMENT.
Patient problems: Failure of Implant; Metal Related Pathology
MAUDE report 19222174 ↗InjurySep 20, 2023Mechanical Problem; Failure to Advance; Material Deformation; Mechanical Problem; Failure to Advance; Material Deformation
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Foreign Body Reaction
MAUDE report 17782957 ↗MalfunctionAug 9, 2023Mechanical Jam; Mechanical Jam
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17492158 ↗MalfunctionJan 3, 2023Break; Break
INFORMATION WAS RECEIVED THAT DURING A CLINIC A PATIENT PRESENTED WITH A BROKEN ROD. THE PATIENT'S PARENTS NOR THE PATIENT RECALL ANY INCIDENT THAT WOULD HAVE CAUSED THE BREAKAGE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16088335 ↗MalfunctionNov 22, 2022Fracture; Fracture
INFORMATION WAS RECEIVED THAT AFTER TAKING X-RAYS POST-DISTRACTION, THE ROD WAS FOUND TO BE BROKEN ABOVE THE DISTAL SCREWS. AS A RESULT, A REVISION PROCEDURE WAS PERFORMED. IT WAS NOTED THAT THE FRACTURE TOOK PLACE NEAR THE END OF THE INTENDED DISTRACTION PERIOD FOR THE PATIENT. NO FURTHER PATIENT IMPACT AND NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 15846469 ↗MalfunctionNov 22, 2022Fracture; Fracture
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO A ROD FRACTURE. IT WAS REPORTED THE ROD HAD ACHIEVED INTENDED DISTRACTION GOALS AND HAD FRACTURED ONLY A SHORT TIME PRIOR TO THE REVISION SURGERY. THERE WAS NO REPORT OF PATIENT FALL, ACCIDENT, OR OTHER TRAUMATIC EVENT. NO FURTHER ADVERSE PATIENT IMPACT AND NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 15846272 ↗MalfunctionJun 17, 2022Fracture; Mechanical Jam; Fracture; Mechanical Jam
DURING EVALUATION OF A RETURNED ROD, IT WAS FOUND THE ROD EXHIBITED A BROKEN RADIAL BEARING AND WOULD NOT DISTRACT. INITIALLY, THE ROD WAS RETURNED WITHOUT A REPORTED PROBLEM AFTER IT HAD BEEN EXPLANTED AS PART OF A PLANNED REMOVAL FOR FINAL FUSION. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734781 ↗MalfunctionJan 12, 2022Fracture; Fracture
INFORMATION WAS RECEIVED THAT THE ROD HAS A BROKEN PIN AND A BROKEN RADIAL BEARING. IT WAS REPORTED THE ROD IS STILL ABLE LENGTHEN. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13240621 ↗MalfunctionNov 30, 2021Mechanical Problem; Mechanical Problem
MalfunctionNov 30, 2021Mechanical Problem; Mechanical Problem
InjuryOct 6, 2021Mechanical Problem; Mechanical Problem
MalfunctionAug 3, 2021Break; Break
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED AS THE ROD WAS BROKEN. NO PATIENT HARM WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12268339 ↗InjuryJun 30, 2021Fracture; Fracture
INFORMATION WAS RECEIVED THAT THE ROD WAS FOUND TO BE BROKEN DURING A CLINIC VISIT. THE ROD WAS ALREADY FULLY DISTRACTED. THE SURGEON OPTED TO LEAVE THE ROD IMPLANTED AND STABILIZED IT BY PLACING A DOMINO CONNECTOR TO THE FIXATION.
Patient problems: Failure of Implant
MAUDE report 12096739 ↗MalfunctionJun 29, 2021Fracture; Fracture
INFORMATION WAS RECEIVED THAT THE ROD WAS FOUND TO BE FRACTURED. THE ROD WAS EXPLANTED; NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 12089657 ↗MalfunctionJun 14, 2021Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE SURGEON BELIEVING THAT THE RODS WERE NOT DEPLOYING DUE TO EXTENDED TIME BETWEEN DISTRACTIONS. NO PATIENT HARM WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 11996244 ↗MalfunctionJun 3, 2021Break; Break
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11935704 ↗InjuryMay 6, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2017. AS PER THE REPORTER THE ROD WAS NOT FUNCTIONING PROPERLY.
Patient problems: Failure of Implant; Pain
MAUDE report 10031418 ↗MalfunctionApr 27, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2019. BASED ON ENGINEERING REVIEW PERFORMED ON (B)(6) 2020, IT WAS IDENTIFIED THAT THE ROD FAILED DISTRACT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10001717 ↗MalfunctionApr 12, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD FAILED TO DISTRACT. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 9951930 ↗InjuryFeb 26, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER REPORTER, THE PATIENT DID NOT LENGTHEN DURING MULTIPLE ATTEMPTS OVER THE LAST YEAR. REPORTEDLY, THE RODS MAY BE JAMMED AND DID NOT REACH THEIR MAXIMUM DISTRACTION LENGTH.
Patient problems: Failure of Implant
MAUDE report 9757163 ↗MalfunctionFeb 20, 2020Mechanical Jam; Mechanical Jam
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS COMPLETED ON (B)(6) 2019. AS PER THE REPORTER, THE RODS WERE JAMMED.
Patient problems: Failure of Implant
MAUDE report 9736118 ↗InjuryFeb 20, 2020Mechanical Jam; Mechanical Jam
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS COMPLETED ON (B)(6) 2019. AS PER REPORTER, THE ROD WAS JAMMED.
Patient problems: Failure of Implant
MAUDE report 9736062 ↗MalfunctionFeb 19, 2020Mechanical Jam; Mechanical Jam
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS COMPLETED ON (B)(6) 2020. AS PER REPORTER, THE ROD WAS JAMMED.
Patient problems: Failure of Implant
MAUDE report 9729120 ↗InjuryDec 20, 2019Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER THE REPORTER THE PATIENT HAD A BROKEN ROD.
Patient problems: Failure of Implant
MAUDE report 9506953 ↗
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 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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