MAGEC® Spinal Bracing and Distraction System MS1-5590SRecalls & reported problems
Nuvasive Specialized Orthopedics, Inc. · Spinal bracing and distraction system, 5.5 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 MAGEC spinal rod system is a magnetic growing-rod implant used to brace and lengthen the spine. The 23 reports mainly describe mechanical failures, including rods not lengthening or distracting, breaking, and showing wear or corrosion; 8 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
- 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 00812258026318), received between Dec 16, 2019 and Aug 3, 2023 — classified as 8 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (8 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.
Most reported problems
Device problems
- Mechanical Problem8
- Break4
- Defective Device4
- Corroded2
- No Apparent Adverse Event2
- Fracture1
- Insufficient Device Problem Information1
- Mechanical Jam1
Patient problems
- Failure of Implant17
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Metal Related Pathology1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2023Break; Break
INFORMATION WAS RECEIVED THAT ROD FRACTURED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: Failure of Implant
MAUDE report 17451494 ↗MalfunctionNov 30, 2022Corroded; Corroded
INFORMATION WAS RECEIVED THAT UPON EXPLANT WHAT APPEARS TO POSSIBLY BE CORROSION OR CALCIFIED TISSUE/BLOOD WAS NOTED ON THE ROD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15886309 ↗MalfunctionNov 30, 2022Corroded; Corroded
INFORMATION WAS RECEIVED THAT UPON EXPLANT WHAT APPEARS TO POSSIBLY BE CORROSION OR CALCIFIED TISSUE/BLOOD WAS NOTED ON THE ROD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15886252 ↗InjuryOct 18, 2022Break; Break
INFORMATION WAS RECEIVED THAT THERE WERE SIGNS OF METALLOSIS AND SLIGHT PISTONING. THE ROD HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; Metal Related Pathology
MAUDE report 15627092 ↗MalfunctionApr 18, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD HAS NOT LENGTHENED AT ALL SINCE IMPLANTATION. THE SURGEON'S COURSE OF ACTION IS UNKNOWN AT THIS TIME. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 14137614 ↗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 13240625 ↗MalfunctionJan 6, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD WAS NOT DISTRACTING. NO PATIENT ADVERSE EVENT WAS REPORTED. THERE ARE NO PLANS AT THIS TIME TO REVISE THE ROD.
Patient problems: Failure of Implant
MAUDE report 13182754 ↗MalfunctionJul 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD EVIDENCE OF WEAR AND DEBRIS, GALLING, CORROSION, SCRATCHING, DISCOLORATION AND MECHANICAL DAMAGE. ADDITIONALLY, THE ROD WAS UNABLE TO BE RETRACTED.
Patient problems: Insufficient Information
MAUDE report 12102167 ↗MalfunctionJul 1, 2021No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD SURFACE WEAR AND DEBRIS, MINOR GALLING, SCRATCHING, DISCOLORATION AND MECHANICAL DAMAGE. ADDITIONALLY, FORCE TESTING WAS UNABLE TO BE PERFORMED AS IT WAS IMPOSSIBLE TO RETRACT THE ROD. NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 12101209 ↗MalfunctionJul 1, 2021No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD WEAR, CORROSION, SCRATCHING, DISCOLORATION, AND MECHANICAL DAMAGE. ADDITIONALLY, FORCE TESTING WAS UNABLE TO BE PERFORMED AS IT WAS IMPOSSIBLE TO RETRACT THE ROD. NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 12100390 ↗MalfunctionApr 22, 2021Break; Mechanical Problem; Break; Mechanical Problem
INFORMATION WAS RECEIVED THAT THERE HAS BEEN DIFFICULTY IN LENGTHENING THE ROD, WITH THE ROD EXPERIENCING SMALL CLICKS. ADDITIONALLY, X-RAYS REVEALED A FRACTURE AT THE ROD'S RADIAL BEARING. A REVISION IS NOT PLANNED AT THIS TIME AND CONTINUED LENGTHENING IS ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11709888 ↗InjuryApr 5, 2021Break; Break
MalfunctionDec 29, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A LOCKING PIN FAILURE.
Patient problems: Failure of Implant
MAUDE report 11085428 ↗MalfunctionDec 28, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD A LOCKING PIN FAILURE.
Patient problems: Failure of Implant
MAUDE report 11085408 ↗MalfunctionAug 12, 2020Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE ROD STOPPED DISTRACTING. REPORTEDLY, METALLOSIS WAS OBSERVED WHEN THE ROD WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10396991 ↗InjuryAug 12, 2020Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE ROD WAS UNABLE TO DISTRACT. REPORTEDLY, METALLOSIS WAS OBSERVED WHEN THE ROD WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10396789 ↗InjuryJul 22, 2020Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE RODS WERE REMOVED ON (B)(6) 2020 AFTER BEING IMPLANTED. AS PER THE REPORTER, THE RODS WOULD NOT PROVIDE ADDITIONAL DISTRACTION IN-SITU.
Patient problems: Failure of Implant
MAUDE report 10312034 ↗InjuryApr 27, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. BASED ON ENGINEERING REVIEW PERFORMED ON (B)(6) 2020, IT WAS IDENTIFIED THAT THE ROD HAD A PIN BREAK.
Patient problems: Failure of Implant
MAUDE report 10001922 ↗MalfunctionApr 11, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A PIN FRACTURE. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 9951725 ↗InjuryApr 10, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 FOR AN UNKNOWN REASON. AS PER THE REPORTER DURING SERVICING IT WAS IDENTIFIED THAT THE O-RING WAS DAMAGED, THE LEAD SCREW HAD SEIZED AND THE DRIVE PIN WAS BROKEN.
Patient problems: Failure of Implant
MAUDE report 9950977 ↗InjuryMar 3, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER REPORTER THE RODS WERE NOT DISTRACTING. REPORTEDLY, UPON REMOVING THE LEFT STANDARD ROD WAS PULLED AND IT BROKE. AS PER REPORTER, THE RIGHT ROD WAS NOT SAVED AFTER REMOVAL, BUT ALSO APPEARED NOT TO BE DISTRACTING WITH THE MANUAL MAGEC MAGNET.
Patient problems: Failure of Implant
MAUDE report 9783257 ↗MalfunctionFeb 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 9736110 ↗InjuryDec 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER REPORTER, THE SURGEON OBSERVED LOOSE SCREWS (UNKNOWN PRODUCT) AT THE LOWER END OF THE CONSTRUCT AND DECIDED TO REVISE THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 9474916 ↗
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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