MAGEC® Spinal Bracing and Distraction System MC2-5570SRecalls & reported problems
Nuvasive Specialized Orthopedics, Inc. · Spinal bracing and distraction system, 5.5 mm standard rod with 70 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
- 14
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00812258022648), received between Oct 16, 2019 and Nov 12, 2024 — classified as 5 injuries, 9 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
- Detachment of Device or Device Component3
- Break2
- Defective Device2
- Migration2
- Fracture1
- Mechanical Problem1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant11
- Insufficient Information4
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2024Break; Failure to Advance; Break; Failure to Advance
INFORMATION HAS BEEN OBTAINED INDICATING THAT THE PATIENT PRESENTED WITH A FAILURE OF THE LOCKING PIN, AS CONFIRMED BY X-RAY ANALYSIS. IT HAS BEEN REPORTED THAT THE ROD DID NOT LENGTHEN AS ANTICIPATED. CONSEQUENTLY, ALL LENGTHENING PROCEDURES HAVE BEEN SUSPENDED PENDING THE ESTABLISHMENT OF DEFINITIVE FUSION.
Patient problems: Failure of Implant
MAUDE report 20669123 ↗MalfunctionAug 20, 2024Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD FAILED FORCE TESTING. ADDITIONALLY, THE EXTERNAL O-RING WAS MISSING FROM THE END CAP, AND IT WAS EASILY REMOVED BY HAND. THE ROD WAS DISASSEMBLED, AND THE THRUST BEARING WAS COVERED WITH MOIST DEBRIS. THE CAGE AND ROLLING ELEMENTS ALSO WERE COVERED IN DEBRIS. THE ROD WAS ONLY PARTIALLY DISASSEMBLED AS THE ROD WAS SEIZED TOGETHER. IT IS UNKNOWN WHY THE ROD WAS REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20005740 ↗MalfunctionAug 13, 2024Break; Failure to Advance; Break; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19977384 ↗MalfunctionAug 13, 2024Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 19977161 ↗InjuryJul 22, 2024Fracture; Failure to Advance; Fracture; Failure to Advance
InjuryJun 19, 2024Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
INFORMATION WAS RECEIVED 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 19570393 ↗MalfunctionJun 20, 2023Failure to Advance; Failure to Advance
INFORMATION WAS RECEIVED THAT THE NAIL WAS TESTED PRIOR TO IMPLANTATION AND WOULD NOT LENGTHEN. THE ROD WAS IMPLANTED AND WAS STILL NOT LENGTHENING, THEREFORE, THE ROD WAS NOT USED.
Patient problems: Failure of Implant
MAUDE report 17164678 ↗MalfunctionSep 15, 2021Mechanical Problem; Mechanical Problem
MalfunctionJul 9, 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 EVIDENCE OF GALLING AND CORROSION. ADDITIONALLY, IT WAS REPORTED THAT THE ROD WAS UNABLE TO BE RETRACTED.
Patient problems: Insufficient Information
MAUDE report 12144524 ↗MalfunctionMay 20, 2020Migration; Migration
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. AS PER THE REPORTER, X-RAYS REVEALED THAT THE END CAP HAD DISENGAGED. THERE IS WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10076721 ↗MalfunctionFeb 28, 2020Migration; Migration
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. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 9771954 ↗InjuryNov 19, 2019Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER REPORTER, THE RODS WERE REMOVED BECAUSE THEY WERE NO LONGER LENGTHENING WITH THE EXTERNAL REMOTE CONTROLLER ERC. THE RODS WERE IMPLANTED FOR APPROXIMATELY 1.5 YEARS.
Patient problems: Failure of Implant
MAUDE report 9345414 ↗InjuryNov 11, 2019Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION SURGERY WAS PERFORMED. AS PER REPORTER, THE RODS STOPPED DISTRACTING AFTER THREE ELONGATIONS AND A BROKEN ROD WAS OBSERVED. REPORTEDLY, DURING THE REMOVAL OF THE ROD, THE SURGEON OBSERVED TISSUE DEBRIS AROUND THE ROD.
Patient problems: Failure of Implant
MAUDE report 9307227 ↗InjuryOct 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
INFORMATION WAS RECEIVED A REVISION PROCEDURE WAS PERFORMED ON SEPTEMBER 30, 2019. AS PER REPORTER, THE END CAP WAS ROTATING OFF THE ROD.
Patient problems: Failure of Implant
MAUDE report 9200515 ↗
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 MC2-5590RNuvasive 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.
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