MAGEC Spinal Bracing and Distraction SystemRecalls & reported problems across all models
Nuvasive Specialized Orthopedics, Inc. · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MAGEC Spinal Bracing and Distraction System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 663
- Deaths reported
- 0
- Injuries reported
- 201
- Recalls
- 1
We found 29 models of MAGEC Spinal Bracing and Distraction System by Nuvasive Specialized Orthopedics, Inc. in the FDA's device registry (GUDID). Together they are named in 663 adverse event reports in the FDA's MAUDE database, received between Jan 18, 2019 and Apr 21, 2025 — classified as 201 injuries, 462 malfunctions.
The most frequently reported specific device problem is “Defective Device” (189 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MAGEC Spinal Bracing and Distraction System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 1, 2022Open, 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 · names 12 of these models · Recall details · FDA record ↗
Most reported MAGEC Spinal Bracing and Distraction System problems
Device problems
- Defective Device189
- Mechanical Jam127
- Corroded114
- Mechanical Problem97
- Failure to Advance77
- Break76
- Fracture35
- Physical Resistance/Sticking35
Patient problems
- Failure of Implant541
- No Clinical Signs, Symptoms or Conditions53
- Insufficient Information39
- Metal Related Pathology18
- Unspecified Infection16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Pain7
- No Known Impact Or Consequence To Patient3
MAGEC Spinal Bracing and Distraction System models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAGEC® Spinal Bracing and Distraction System RA002-5555SLGrowing Rod System- Magnetic Actuation112 reports
- MAGEC® Spinal Bracing and Distraction System RA002-4545SLGrowing Rod System- Magnetic Actuation82 reports
- MAGEC® Spinal Bracing and Distraction System RA002-5555SLRGrowing Rod System- Magnetic Actuation81 reports
- MAGEC® Spinal Bracing and Distraction System MC2-5590SGrowing Rod System- Magnetic Actuation1 recall26 reports
- MAGEC® Spinal Bracing and Distraction System MC2-4590SGrowing Rod System- Magnetic Actuation1 recall25 reports
- MAGEC® Spinal Bracing and Distraction System MC2-4570SGrowing Rod System- Magnetic Actuation1 recall14 reports
- MAGEC® Spinal Bracing and Distraction System MC2-5570SGrowing Rod System- Magnetic Actuation1 recall14 reports
- MAGEC® Spinal Bracing and Distraction System MC2-5590RGrowing Rod System- Magnetic Actuation1 recall11 reports
- MAGEC® Spinal Bracing and Distraction System MC2-6090SGrowing Rod System- Magnetic Actuation1 recall10 reports
- MAGEC® Spinal Bracing and Distraction System RA002-4545SLRGrowing Rod System- Magnetic Actuation60 reports
- MAGEC® Spinal Bracing and Distraction System MC2-4570RGrowing Rod System- Magnetic Actuation1 recall8 reports
- MAGEC® Spinal Bracing and Distraction System MC2-6090RGrowing Rod System- Magnetic Actuation1 recall5 reports
- MAGEC® Spinal Bracing and Distraction System MC2-5570RGrowing Rod System- Magnetic Actuation1 recall3 reports
- MAGEC® Spinal Bracing and Distraction System MC2-4590RGrowing Rod System- Magnetic Actuation1 recall1 report
- MAGEC® Spinal Bracing and Distraction System MC2-6070SGrowing Rod System- Magnetic Actuation1 recall1 report
- MAGEC® Spinal Bracing and Distraction System MC2-6070RGrowing Rod System- Magnetic Actuation1 recall1 report
- MAGEC® Spinal Bracing and Distraction System RA002-4545SL70Growing Rod System- Magnetic Actuation38 reports
- MAGEC® Spinal Bracing and Distraction System RA002-4545SLR70Growing Rod System- Magnetic Actuation31 reports
- MAGEC® Spinal Bracing and Distraction System MS1-4590SGrowing Rod System- Magnetic Actuation30 reports
- MAGEC® Spinal Bracing and Distraction System MS1-5590SGrowing Rod System- Magnetic Actuation23 reports
- MAGEC® Spinal Bracing and Distraction System RA002-5555SL70Growing Rod System- Magnetic Actuation21 reports
- MAGEC® Spinal Bracing and Distraction System MS1-4570SGrowing Rod System- Magnetic Actuation19 reports
- MAGEC® Spinal Bracing and Distraction System RA002-5555SLR70Growing Rod System- Magnetic Actuation15 reports
- MAGEC® Spinal Bracing and Distraction System MS1-4590RGrowing Rod System- Magnetic Actuation10 reports
- MAGEC® Spinal Bracing and Distraction System MS1-4570RGrowing Rod System- Magnetic Actuation10 reports
- MAGEC® Spinal Bracing and Distraction System MS1-5590RGrowing Rod System- Magnetic Actuation6 reports
- MAGEC® Spinal Bracing and Distraction System MS1-5570SGrowing Rod System- Magnetic Actuation4 reports
- MAGEC® Spinal Bracing and Distraction System MS2-6090SGrowing Rod System- Magnetic Actuation1 report
- MAGEC® Spinal Bracing and Distraction System MS1-5570RGrowing Rod System- Magnetic Actuation1 report
Recent MAGEC Spinal Bracing and Distraction System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED 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 21875661 ↗MalfunctionMar 18, 2025Break; Break
INFORMATION WAS RECEIVED THAT THE DURING A LENGTHENING SESSION, X-RAY IMAGES REVEALED A LOCKING PIN FAILURE. AS THE PATIENT IS AT THE END OF THEIR LENGTHENING, THE ROOD WILL NOT BE REPLACED AND PATIENT WILL CONTINUE TO DEFINITIVE FUSION.
Patient problems: Failure of Implant
MAUDE report 21633900 ↗InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REVISION PROCEDURE WAS PERFORMED AFTER SEVERAL INCISION AND DRAINAGE (I&D) PROCEDURES TO ADDRESS AN ABSCESS WITH WOUND CLOSURE. THIS WAS REQUIRED DUE TO AN INFECTION FOLLOWING DEVICE IMPLANTATION.
Patient problems: Drug Resistant Bacterial Infection
MAUDE report 20835908 ↗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 ↗InjuryOct 23, 2024Failure to Advance; Failure to Advance
INFORMATION WAS RECEIVED THAT ONE OF THE IMPLANTED RODS FAILED TO LENGTHEN SO BOTH RODS WERE REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 20517467 ↗InjuryOct 23, 2024Failure to Advance; Failure to Advance
INFORMATION WAS RECEIVED THAT ONE OF THE IMPLANTED RODS FAILED TO LENGTHEN SO BOTH RODS WERE REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 20516591 ↗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 14, 2024Failure to Advance; Failure to Advance
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD FAILED FORCE TESTING. THERE WAS DEBRIS SEEN IN THE ROD, ALTHOUGH IT WAS ONLY PARTIALLY DISASSEMBLED. ADDITIONALLY, THE LEADSCREW WAS FOUND TO BE SEIZED WITHIN THE EXTENDING BAR. IT IS UNKNOWN WHY THE ROD WAS REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19983655 ↗MalfunctionAug 14, 2024Failure to Advance; Failure to Advance
AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD FAILED FORCE TESTING. THE ROD WAS DISASSEMBLED AND SUBSTANTIAL DEBRIS WAS SEEN AROUND THE LEADSCREW, THE RADIAL BEARING, AND THE EXTENDING BAR. ADDITIONALLY THE LEADSCREW WAS FOUND TO BE SEIZED WITHIN THE EXTENDING BAR. IT IS UNKNOWN WHY THE ROD WAS REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19983552 ↗MalfunctionAug 14, 2024Failure to Advance; Failure to Seal; Failure to Advance; Failure to Seal
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information; Metal Related Pathology
MAUDE report 19983341 ↗MalfunctionAug 14, 2024Break; Failure to Advance; Break; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19983194 ↗InjuryAug 14, 2024Break; Failure to Advance; Break; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19982049 ↗MalfunctionAug 14, 2024Break; Failure to Advance; Break; Failure to Advance
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19981711 ↗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 ↗
Other Nuvasive Specialized Orthopedics, Inc. products
- PRECICE Intramedullary Limb Lengthening System551 models · 177 reports · 4 recalls
- PRECICE STRYDE System231 models · 139 reports · 2 recalls
- PRECICE Bone Transport System561 models · 28 reports · 3 recalls
- PRECICE Plating System67 models · 24 reports · 3 recalls
- PRECICE Trauma Nail System182 models · 4 reports · 3 recalls
- FREEDOM Residual Limb Lengthening System2 models · 1 reports · 2 recalls
- Precice38 models · 9 reports · 1 recall
- PRECICE System15 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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