MAGEC® Spinal Bracing and Distraction System MC2-4590SRecalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This MAGEC spinal growth-rod system is intended to support and gradually lengthen the spine. Reports mostly describe rods that fail to lengthen or have other mechanical problems, sometimes leading to revision surgery; there are 25 reports, 5 injuries, and no deaths. One open recall began in November 2022 over packaging that might fail to keep the device 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
- 25
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00812258022624), received between Jan 13, 2020 and Apr 21, 2025 — classified as 5 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance7
- Mechanical Problem4
- Migration or Expulsion of Device4
- Break2
- Detachment of Device or Device Component2
- Fracture2
- Mechanical Jam2
- Naturally Worn2
Patient problems
- Failure of Implant20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Metal Related Pathology2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD FAILING TO DISTRACT. THE REVISION SURGERY WAS COMPLETED WITH NO ISSUE OR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 21875661 ↗MalfunctionAug 14, 2024Break; Failure to Advance; Break; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19983194 ↗InjuryAug 13, 2024Failure to Advance; Failure to Advance
MalfunctionMar 23, 2024Failure to Advance; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 18965572 ↗InjuryJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
UPON FURTHER REVIEW, THIS REPORT HAS BEEN DETERMINED TO BE A DUPLICATE OF MFR # 3006179046-2024-00100. THE RECORD ASSOCIATED WITH THIS REPORT WILL BE VOIDED AND ALL RELEVANT INFORMATION WILL BE DOCUMENTED AND REPORTED UNDER MFR # 3006179046-2024-00100.
Patient problems: Metal Related Pathology
MAUDE report 18597324 ↗InjuryJan 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Metal Related Pathology
MAUDE report 18520247 ↗MalfunctionSep 12, 2023Failure to Advance; Failure to Advance
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD NOT LENGTHENING AFTER MULTIPLE ATTEMPTS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 17732666 ↗MalfunctionJul 26, 2023Fracture; Fracture
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17398277 ↗MalfunctionJul 26, 2023Structural Problem; Structural Problem
INFORMATION WAS RECEIVED THAT THE LEFT SIDE ROD'S O-RING WAS DISPLACED IN 2019. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS BLACKENING OF THE TISSUE AROUND THE ACTUATOR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17398263 ↗MalfunctionJan 18, 2023Failure to Advance; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16196461 ↗MalfunctionJan 18, 2023Failure to Advance; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16196336 ↗MalfunctionJul 28, 2022Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn
INFORMATION WAS RECEIVED THAT THE ROD HAS FAILED TO LENGTHEN AFTER (B)(6) 2020. AS PER THE REPORTER, THE ROD IS POSSIBLY JAMMED AND THERE WAS NOTICEABLE WEAR DEBRIS IN-SITU. NO PATIENT INJURY WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 15125166 ↗MalfunctionJul 28, 2022Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn
INFORMATION WAS RECEIVED THAT THE ROD HAS FAILED TO LENGTHEN AFTER (B)(6) 2020. AS PER THE REPORTER, THE ROD IS POSSIBLY JAMMED AND THERE WAS NOTICEABLE WEAR DEBRIS IN-SITU. NO PATIENT INJURY WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 15125130 ↗MalfunctionJan 5, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD FAILED TO REACH TERMINAL DISTRACTION LENGTHEN. THE RODS WERE REMOVED FOR FINAL FUSION WITH A COMPETITOR PRODUCT. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13162943 ↗MalfunctionJan 5, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD FAILED TO REACH TERMINAL DISTRACTION LENGTHEN. THE RODS WERE REMOVED FOR FINAL FUSION WITH A COMPETITOR PRODUCT. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 13162870 ↗MalfunctionJun 4, 2021Mechanical Problem; Mechanical Problem
MalfunctionJun 4, 2021Mechanical Problem; Mechanical Problem
MalfunctionMar 8, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT X-RAYS SHOWED THE ACTUATOR END CAP IS MOVING WITH THE ROD. THERE IS NO REVISION PROCEDURE PLANNED AT THIS TIME. NO PATIENT INJURY WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 11439902 ↗MalfunctionMar 1, 2021Break; Break
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE DUE TO A BROKEN ROD. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD WAS BROKEN.
Patient problems: Failure of Implant
MAUDE report 11397107 ↗MalfunctionDec 30, 2020Unstable; 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 11098839 ↗MalfunctionDec 29, 2020Fracture; Fracture
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED (B)(6) 2019. AS PER THE REPORTER THE ROD FRACTURED. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) 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 11091224 ↗MalfunctionAug 18, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. AS PER THE REPORTER, X-RAY IMAGES REVEALED THAT THE END CAP HAD MIGRATED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10423745 ↗MalfunctionJul 31, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, X-RAY IMAGES REVEALED THE END CAP DISCONNECTED FROM THE ACTUATOR. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10348638 ↗MalfunctionJul 17, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED AFTER THE THIRD LENGTHENING OF THE RODS, X-RAY IMAGES REVEALED THAT THE END CAP HAD LOOSENED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10292813 ↗InjuryJan 13, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT X-RAYS REVEALED THAT THE END CAP HAD DISENGAGED. AT THIS TIME IT IS UNKNOWN IF THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 9583884 ↗
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 MC2-4570SNuvasive 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