MAGEC® Spinal Bracing and Distraction System RA002-5555SL70Recalls & 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
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00856719002152), received between Mar 13, 2020 and May 31, 2023 — classified as 6 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Defective Device” (10 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
- Defective Device10
- Mechanical Jam4
- Break2
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
- Corroded1
- Defective Component1
- Fluid/Blood Leak1
Patient problems
- Failure of Implant18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2023Mechanical Jam; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WOULD NOT DISTRACT AND FORCE TESTING WAS UNABLE TO BE PERFORMED. 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 17031633 ↗MalfunctionMay 31, 2023Mechanical Jam; Mechanical Jam
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WOULD NOT DISTRACT AND FORCE TESTING WAS UNABLE TO BE PERFORMED AS THE ELECTRONIC REMOTE CONTROLLER (ERC) WAS NOT FUNCTIONAL. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING. 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 17031590 ↗InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED FOR THE REMOVAL THE MAGEC ROD AND CONVERSION TO DEFINITIVE FUSION. AS PER THE REPORTER, THERE WERE A LOT OF BLACK STAINS TO THE TISSUE WHERE THE RODS HAD BEEN LENGTHENING. THERE WAS NO INFECTION OR NECROSIS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. REPORT 1 OF 2.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15105755 ↗MalfunctionJun 22, 2022Break; Corroded; Mechanical Jam; Naturally Worn; Scratched Material; Break; Corroded; Mechanical Jam; Naturally Worn; Scratched Material
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND A PIN FRACTURE AND THE ROD WAS JAMMED. ADDITIONALLY, WEAR, CORROSION, SCRATCHING, DISCOLORATION AND OTHER SURFACE DAMAGE WERE NOTED. ALSO, DEBRIS WAS FOUND INSIDE THE HOUSING TUBE. IT WAS REPORTED THAT THE ROD WAS REMOVED AS PART OF A PLANNED REMOVAL PROCEDURE AFTER THE ROD HAD FULLY EXTENDED; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 14780388 ↗MalfunctionFeb 14, 2022Fluid/Blood Leak; Migration or Expulsion of Device; Fluid/Blood Leak; Migration or Expulsion of Device
INFORMATION WAS RECEIVED THAT THE END CAP WAS LOOSE ON THE ROD AND LIQUID HAD ESCAPED. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13528736 ↗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. ADDITIONALLY, IT WAS REPORTED THAT THE ROD WAS UNABLE TO BE RETRACTED.
Patient problems: Insufficient Information
MAUDE report 12144412 ↗MalfunctionMar 1, 2021Mechanical Jam; Mechanical Jam
InjuryFeb 16, 2021Break
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. AS PER THE REPORTER, X-RAY IMAGES REVEAL THAT THE ROD WAS BROKEN IN TWO PIECES. THE PATIENT DID NOT REPORT ANY DISCOMFORT OR PAIN DURING THE DISTRACTION PROCESS.
Patient problems: Failure of Implant
MAUDE report 11336197 ↗MalfunctionDec 29, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED 38 MONTHS AFTER BEING IMPLANTED. AS PER THE REPORTER THE ROD FAILED TO LENGTHEN. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD PRESENCE OF PIN FRACTURE AND DEBRIS IN HOUSING TUBE.
Patient problems: Failure of Implant
MAUDE report 11092262 ↗MalfunctionOct 19, 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 LENGTHEN. AS PER REPORTER, WHEN THE ROD WAS EXPLANTED THE STANDARD MAGEC ROD WAS TESTED WITH A MANUAL DISTRACTOR AND WAS STILL FUNCTIONING.
Patient problems: Failure of Implant
MAUDE report 10701931 ↗MalfunctionSep 4, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE ROD FAILED TO EXTEND.
Patient problems: Failure of Implant
MAUDE report 10497380 ↗InjuryMay 3, 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 SERVICE IT WAS IDENTIFIED THAT THE DRIVE PIN WAS BROKEN AND THE O-RING SEAL HAD SNAPPED.
Patient problems: Failure of Implant
MAUDE report 10019785 ↗InjuryApr 27, 2020Defective Component; Defective Component
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. BASED ON ENGINEERING REVIEW PERFORMED ON (B)(6) 2020, IT WAS IDENTIFIED THAT THE ROD HAD A BROKEN SEAL. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 10001428 ↗InjuryApr 12, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 FOR AN UNKNOWN REASON. AS PER THE REPORTER DURING SERVICE IT WAS IDENTIFIED THAT THERE WAS A PIN FRACTURE AND A LARGE AMOUNT OF DEBRIS IN THE HOUSING TUBE.
Patient problems: Failure of Implant
MAUDE report 9951926 ↗InjuryApr 12, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER THE REPORTER DURING SERVICE IT WAS IDENTIFIED THAT THERE WAS A PIN FRACTURE DEBRIS IN HOUSING TUBE.
Patient problems: Failure of Implant
MAUDE report 9951917 ↗MalfunctionApr 11, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A PIN FRACTURE AND A COMPROMISED O-RING. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 9951675 ↗MalfunctionApr 10, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2017 FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A COMPROMISED O-RING. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 9950947 ↗MalfunctionApr 10, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2017 FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT ROD HAD A PIN FRACTURE. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 9950687 ↗MalfunctionMar 13, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER REPORTER THE ROD WAS REMOVED DUE TO COMPLETE EXTENSION. AS PER REPORTER, VISUAL INSPECTION REVEAL THAT THERE WAS COLD WELDING BETWEEN THE HOUSING TUBE AND THE DISTRACTION ROD.
Patient problems: Failure of Implant
MAUDE report 9830387 ↗MalfunctionMar 13, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 DUE TO FINAL EXTENSION. DURING INVESTIGATION IMAGES REVEALED A BROKEN PIN.
Patient problems: Failure of Implant
MAUDE report 9830125 ↗MalfunctionMar 13, 2020Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER THE REPORTER, THE RODS WERE REMOVED FOR FINAL FUSION.
Patient problems: Failure of Implant
MAUDE report 9829869 ↗
Other Growing Rod System- Magnetic Actuation devices
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- 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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