MAGEC® Spinal Bracing and Distraction System MC2-5590RRecalls & reported problems
Nuvasive Specialized Orthopedics, Inc. · Spinal bracing and distraction system, 5.5 mm offset 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.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00812258022679), received between Jul 9, 2020 and Aug 14, 2024 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Migration” (3 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
- Migration3
- Migration or Expulsion of Device3
- Mechanical Problem2
- Break1
- Corroded1
- Failure to Advance1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant8
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Break; Failure to Advance; Break; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19981711 ↗MalfunctionJun 16, 2023Mechanical Jam; 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 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 17148919 ↗MalfunctionAug 9, 2022Migration; Migration
INFORMATION WAS RECEIVED THAT THE RIGHT SIDE ROD HAS ENDCAP SEPARATION. THE PATIENT IS ASYMPTOMATIC AND THE ROD IS STILL LENGTHENING. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 15192417 ↗MalfunctionApr 18, 2022Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT IMMEDIATELY UPON CLOSING, LENGTHENING WAS ATTEMPTED AND THE LEFT ROD WAS NOT LENGTHENING. SURGEON PLANS TO MONITOR AND CONTINUE TO TRY TO LENGTHEN. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 14137600 ↗MalfunctionSep 24, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT THE END CAP CAME OFF AND THE ROD WAS UNABLE TO DISTRACT. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12528408 ↗MalfunctionSep 9, 2021Corroded; Fracture; Corroded; Fracture
INFORMATION WAS RECEIVED THAT THE MAGNET APPEARED TO BE FRACTURED INTERNALLY AND DISASSOCIATED. ADDITIONALLY, IT WAS REPORTED THAT FRETTING/CORROSION IS VISIBLE. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12447032 ↗MalfunctionJul 13, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT END CAP LOOSENED. NO PATIENT HARM WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12162165 ↗MalfunctionJul 9, 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 GALLING.
Patient problems: Insufficient Information
MAUDE report 12144749 ↗MalfunctionJun 3, 2021Migration; Migration
INFORMATION WAS RECEIVED THAT AFTER THE FOURTH APPOINTMENT FOR LENGTHENING, THE MAGEC ROD END CAP WAS LOOSE. A REVISION PROCEDURE IS PLANNED BUT HAS YET TO OCCUR.
Patient problems: Insufficient Information
MAUDE report 11930954 ↗InjuryJul 17, 2020Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration
INFORMATION WAS RECEIVED THAT PRIOR TO THE FIRST DISTRACTION, X -RAY IMAGES REVEALED LOOSENING OF THE END CAP. A REVISION PROCEDURE IS NOT PLANNED AT THIS TIME. THERE WAS NO PATIENT INJURY REPORTED. AS PER THE SURGEON, THE INITIAL DISTRACTION SESSION WENT WELL.
Patient problems: Failure of Implant
MAUDE report 10290767 ↗MalfunctionJul 9, 2020Mechanical Problem; Mechanical Problem
AS PER REPORTER THE FIRST X-RAY (PRIOR TO 1ST DISTRACTION) X-RAY INDICATED A LOOSENING OF THE ENDCAP. FIRST DISTRACTION WENT WELL, NO REVISION PROCEDURE IS PLANNED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 10255596 ↗
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 · 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