MAGEC® Spinal Bracing and Distraction System MS1-4590RRecalls & reported problems
Nuvasive Specialized Orthopedics, Inc. · Spinal bracing and distraction system, 4.5 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
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00812258026301), received between Aug 29, 2019 and Apr 18, 2024 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (4 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
- Mechanical Problem4
- Defective Device3
- Degraded2
- Break1
- Fracture1
- Material Discolored1
Patient problems
- Failure of Implant8
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- Pain1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2024Break; Break
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 19140424 ↗MalfunctionJul 7, 2021Mechanical Problem; Mechanical Problem
CORRECTED DEVICE INFORMATION WAS PROVIDED.
Patient problems: Failure of Implant
MAUDE report 12132597 ↗MalfunctionJul 1, 2021Degraded; Fracture; Degraded; Fracture
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD HAVING A PIN FRACTURE. DURING A REVIEW OF INVESTIGATION FINDINGS FROM THE (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A PIN FRACTURE WITH DEBRIS IN THE HOUSING TUBE, AND THE PRESENCE OF DISCOLORATION/CORROSION WAS NOTED.
Patient problems: Failure of Implant
MAUDE report 12105068 ↗MalfunctionJul 1, 2021Material Discolored; Material Discolored
IT WAS REPORTED THAT AN EXPLANT PROCEDURE WAS PERFORMED SINCE THE ROD WAS FULLY EXTENDED; HOWEVER, DURING A REVIEW OF INVESTIGATION FINDINGS FROM THE (B)(6), IT WAS IDENTIFIED THAT THE ROD HAD MINOR DISCOLORATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12105050 ↗MalfunctionJul 1, 2021Degraded; Mechanical Problem; Degraded; Mechanical Problem
IT WAS REPORTED THAT A ROD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON; HOWEVER, DURING A REVIEW OF INVESTIGATION FINDINGS FROM THE (B)(6), IT WAS IDENTIFIED THAT THE ROD WAS UNABLE TO RETRACT AND MINOR DISCOLORATION WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12104971 ↗MalfunctionNov 4, 2020Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THE ROD WAS NOT LENGTHENING WELL. THERE WAS NO PATIENT INJURY REPORTED AND IT IS UNKNOWN IF A REVISION PROCEDURE IS PLANNED.
Patient problems: Failure of Implant
MAUDE report 10787325 ↗MalfunctionSep 19, 2020Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT X-RAY IMAGES TAKEN (B)(6) 2019, IDENTIFIED A LOCKING PIN FAILURE. THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF A REVISION PROCEDURE IS PLANNED.
Patient problems: Failure of Implant
MAUDE report 10557815 ↗InjuryMay 6, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. AS PER THE REPORTER THE ROD WAS NOT FUNCTIONING PROPERLY .
Patient problems: Failure of Implant; Pain
MAUDE report 10031422 ↗MalfunctionApr 8, 2020Defective Device; Defective Device
SEE UPDATED INFORMATION IN H2, H3, H6 AND H10.
Patient problems: Failure of Implant
MAUDE report 9938544 ↗MalfunctionAug 29, 2019Defective Device; Defective Device
INFORMATION RECEIVED ALLEGED A PIN BREAK WAS NOTED. ON (B)(6) 2018 A REVISION PROCEDURE WAS PERFORMED TO EXCHANGE THE DAMAGED ROD FOR BIGGER SIZES TO TAKE THE PATIENT THROUGH TO DEFINITIVE FUSION.
Patient problems: Failure of Implant
MAUDE report 8945708 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page