MAGEC® Spinal Bracing and Distraction System RA002-4545SLRRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00856719002138), received between Feb 20, 2020 and Jul 26, 2024 — classified as 20 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Defective Device” (29 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

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Break; Degraded; Material Discolored; Failure to Advance; Physical Resistance/Sticking; Break; Degraded; Material Discolored; Failure to Advance; Physical Resistance/Sticking

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WOULD NOT DISTRACT OR RETRACT AND FORCE TESTING WAS UNABLE TO BE PERFORMED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS WEAR, SCRATCHING, DISCOLORATION, AND MECHANICAL DAMAGE. UPON DISASSEMBLY OF THE ROD, DEBRIS WAS FOUND IN THE HOUSING TUBE AND PRESENCE OF A PIN FRACTURE THERE WAS ALSO A BROKEN MAGNET, COLD-WELDING BETWEEN THE HOUSING TUBE AND THE DISTRACTION ROD, AND THE DISTRACTION ROD WAS STUCK IN THE HOUSING TUBE. IT IS UNKNOWN WHY THE ROD WAS REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19839660 ↗
• MalfunctionOct 3, 2023Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17862033 ↗
• MalfunctionAug 3, 2023Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT DURING X-RAY IT WAS DISCOVERED THAT THE ROD DID NOT DISTRACT AT ALL. THE ROD WAS REMOVED AND REPLACED WITH A NEW ROD.

  Patient problems: Failure of Implant

  MAUDE report 17451651 ↗
• MalfunctionJun 16, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT FORCE TESTING WAS UNABLE TO BE COMPLETED DUE TO THE EXTERNAL REMOTE CONTROLLER (ERC) NOT BEING FUNCTIONAL. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION 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 17148911 ↗
• MalfunctionJun 16, 2023Corroded; Mechanical Jam; Corroded; 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 AND CORROSION 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 17148906 ↗
• MalfunctionJun 16, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT FORCE TESTING WAS UNABLE TO BE COMPLETED DUE TO THE EXTERNAL REMOTE CONTROLLER (ERC) NOT FUNCTIONING. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION 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 17148838 ↗
• MalfunctionJun 16, 2023Corroded; Mechanical Jam; Corroded; 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 CORROSION 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 17144901 ↗
• MalfunctionMay 31, 2023Corroded; Mechanical Jam; Corroded; 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. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS CORROSION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17035179 ↗
• MalfunctionMay 31, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, 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 CORROSION AND GALLING. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO THE ROD NOT DISTRACTING AS THE PATIENT WAS OBESE. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17033395 ↗
• MalfunctionMay 31, 2023Break; Corroded; Mechanical Jam; Break; Corroded; Mechanical Jam

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17031873 ↗
• MalfunctionMay 26, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, FORCE TESTING WAS UNABLE TO BE PERFORMED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION. 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 17014607 ↗
• MalfunctionMay 26, 2023Break; Corroded; Mechanical Jam; Break; Corroded; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, FORCE TESTING WAS UNABLE TO BE PERFORMED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO A BROKEN PIN AND HIGH ENERGY X-RAY EVALUATION REVEAL EVIDENCE OF A PIN FRACTURE. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17012002 ↗
• MalfunctionMay 26, 2023Corroded; Migration or Expulsion of Device; Mechanical Jam; Corroded; Migration or Expulsion of Device; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, 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 AND CORROSION ON THE ROD. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO DISTAL PULLOUT; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17011334 ↗
• MalfunctionFeb 15, 2023Failure to Advance; Material Protrusion/Extrusion; Physical Resistance/Sticking; Failure to Advance; Material Protrusion/Extrusion; Physical Resistance/Sticking

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD EXERTED NO FORCE DURING TESTING. ADDITIONALLY, THE ROD WAS SEIZED TOGETHER AND WAS IMPOSSIBLE TO DISASSEMBLE AND A PORTION OF THE MAGNET WAS PROTRUDING FROM THE OUTER CASING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16379878 ↗
• MalfunctionFeb 10, 2023Break; Degraded; Mechanical Problem; Structural Problem; Failure to Advance; Break; Degraded; Mechanical Problem; Structural Problem; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16358858 ↗
• MalfunctionFeb 10, 2023Degraded; Structural Problem; Failure to Advance; Physical Resistance/Sticking; Degraded; Structural Problem; Failure to Advance; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16358806 ↗
• MalfunctionFeb 10, 2023Break; Degraded; Structural Problem; Failure to Advance; Physical Resistance/Sticking; Break; Degraded; Structural Problem; Failure to Advance; Physical Resistance/Sticking

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THE ROD EXERTED NO FORCE DURING FORCE TESTING. ADDITIONALLY, THE ROD WAS REPORTED TO HAVE BEEN PISTONING AND THE DRIVE PIN WAS BROKEN. THE O-RING SEAL WAS REPORTED TO HAVE BEEN VERY BADLY DAMAGED, MISSHAPEN, AND COPIOUS BLACK DEBRIS WAS NOTED. THE RADIAL BEARING WAS FOUND TO BE BROKEN AND SEIZED TO THE MAGNET. THE LEAD SCREW WAS ALSO SEIZED INSIDE THE EXTENDING BAR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16358698 ↗
• MalfunctionFeb 10, 2023Break; Corroded; Degraded; Structural Problem; Failure to Advance; Detachment of Device or Device Component; Material Protrusion/Extrusion; Material Twisted/Bent; Physical Resistance/Sticking; Break; Corroded; Degraded; Structural Problem; Failure to Advance; Detachment of Device or Device Component; Material Protrusion/Extrusion; Material Twisted/Bent; Physical Resistance/Sticking

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THE ROD EXERTED NO FORCE DURING FORCE TESTING. ADDITIONALLY, THE EXTENDING BAR WAS REPORTED TO NOT BE PARALLEL WITH THE OUTER CASING. THE ROD WAS REPORTEDLY POSITIONING, INDICATING THAT THE DRIVE PIN WAS FRACTURED. UPON INITIAL DISASSEMBLY, THE RACE AND SOME OF THE ROLLING ELEMENTS WERE FOUND TO BE COVERED WITH SOME RUST-COLORED DEBRIS. FURTHER DISASSEMBLY REVEALED THAT THE MAGNET WAS DETACHED FROM THE LEAD SCREW AND THE DRIVE PIN WAS IN FACT SNAPPED. THE LEAD SCREW WAS PROTRUDING FROM THE OUTER CASING. IT WAS ADDITIONALLY REPORTED THAT THE LEAD SCREW WAS SEIZED WITHIN THE EXTENDING BAR AND THE O-RING HAD SNAPPED.

  Patient problems: Failure of Implant

  MAUDE report 16356384 ↗
• MalfunctionFeb 10, 2023Structural Problem; Failure to Advance; Physical Resistance/Sticking; Structural Problem; Failure to Advance; Physical Resistance/Sticking

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THE ROD EXERTED 35.3LBF DURING FORCE TESTING WHICH DID NOT MEET THE SPECIFICATION. ADDITIONALLY, UPON INITIAL DISASSEMBLY THE MAGNET, RADIAL BEARING, AND EXTENDING BAR WERE FOUND TO BE SEIZED TOGETHER AND THE COMPONENTS WERE UNABLE TO BE SEPARATED, THEREFORE, THE DRIVE PIN WAS UNABLE TO BE EXAMINED. IT WAS ADDITIONALLY REPORTED THAT THE O-RING SEAL WAS FOUND TO HAVE BEEN SNAPPED IN THREE PIECES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16353731 ↗
• MalfunctionOct 29, 2022Break; Corroded; Failure to Advance; Mechanical Jam; Break; Corroded; Failure to Advance; 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. DEVICE X-RAYS TAKEN DURING THE EVALUATION REVEALED CLEAR EVIDENCE OF PIN FRACTURE. ADDITIONALLY, IT WAS REPORTED THAT DURING SURFACE DAMAGE GRADING THERE WAS SOME GALLING AND CORROSION OBSERVED AROUND THE TELESCOPIC ROD. UPON DISASSEMBLY OF THE ROD, THE PIN FRACTURE WAS CONFIRMED AND THERE WAS DEBRIS FOUND IN THE CONSTRUCT WITHIN THE PIN HOUSING. THE REASON FOR REMOVAL WAS REPORTEDLY DUE TO THE PIN FRACTURE. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695253 ↗
• MalfunctionOct 27, 2022Corroded; Failure to Advance; Mechanical Jam; Corroded; Failure to Advance; 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. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION AROUND THE TELESCOPIC 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. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685380 ↗
• InjuryJun 8, 2022Corroded; Fracture; Naturally Worn; Scratched Material; Corroded; Fracture; Naturally Worn; Scratched Material

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD EXPERIENCING A PIN FRACTURE. DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND CORROSION AND DISCOLORATION ON THE ROD. ADDITIONALLY, WEAR, SCRATCHES, AND OTHER SURFACE DAMAGE WAS NOTED. THERE WAS NO FURTHER REPORTED PATIENT IMPACT AND NO PATIENT OR USER INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 14629723 ↗
• MalfunctionFeb 8, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT AFTER FIVE YEARS OF BEING IMPLANTED, A REVISION PROCEDURE WAS PERFORMED DUE TO THE RODS ONLY DISTRACTING 3 CENTIMETERS. AFTER REMOVAL, THE ROD WOULD NOT DISTRACT WHILE UTILIZING MANUAL DISTRACTION, HOWEVER, A "CLICK" COULD BE HEARD. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 13481564 ↗
• 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 AND CORROSION. ADDITIONALLY IT WAS REPORTED THAT THE ROD WAS UNABLE TO BE RETRACTED.

  Patient problems: Insufficient Information

  MAUDE report 12144829 ↗
• MalfunctionJul 7, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 12132067 ↗