MAGEC® Spinal Bracing and Distraction System RA002-4545SL70Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00856719002244), received between Mar 13, 2020 and Jun 16, 2023 — classified as 6 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (16 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2023Break; Mechanical Jam; Break; 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 ON THE ROD. UPON DISASSEMBLY, A FRACTURED SURFACE WAS OBSERVED. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO EXCHANGE WITH TRADITIONAL GROWING RODS; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17148832 ↗
• MalfunctionJun 1, 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. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO THE CONTRALATERAL SIDE ROD BEING BROKEN; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17039214 ↗
• MalfunctionJun 1, 2023Mechanical Jam; 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. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO PROGRESSION OF LUMBAR SCOLIOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17038738 ↗
• MalfunctionMay 31, 2023Break; Mechanical Jam; Break; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WAS NOT CONFORM FOR FORCE TESTING. PHOTOS OF THE ROD SHOWED THE ROD WAS BROKEN. 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 17035212 ↗
• MalfunctionMay 31, 2023Break; Corroded; Mechanical Jam; Break; Corroded; Mechanical Jam

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17035192 ↗
• 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. IT WAS REPORTED THAT THE ROD WAS REMOVED AS PART OF A PLANNED REMOVAL PROCEDURE TO CONVERT THE PATIENT TO FINAL FUSION; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17034870 ↗
• 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. UPON DISASSEMBLY OF THE ROD IT WAS NOTICED THAT THERE WAS A DAMAGED RADIAL BEARING. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO A BROKEN ROD AT THE SOLID SECTION FROM AN ACCIDENT ON THE TRAMPOLINE. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17014573 ↗
• MalfunctionMay 26, 2023Break; Corroded; Break; Corroded

  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. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO A BROKEN ROD AT THE SOLID SECTION. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17012422 ↗
• MalfunctionFeb 15, 2023Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD WAS TESTED IN A JIG WITH AN EXTERNAL REMOTE CONTROLLER (ERC) AND IT EXERTED NO FORCE. ADDITIONALLY IT WAS FOUND THAT THE OUTER CASING, MAGNET AND EXTENDING BAR HAD SEIZED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16381084 ↗
• MalfunctionFeb 10, 2023Corroded; Degraded; Structural Problem; Failure to Advance; Corroded; Degraded; Structural Problem; Failure to Advance

  INFORMATION WAS RECEIVED THAT ONCE THE ROD WAS REMOVED THERE APPEARED TO BE SOME MOVEMENT IN THE ROD WHICH MAY BE DUE TO THE FORCE USED DURING THE REMOVAL PROCEDURE. 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 TESTING. ADDITIONALLY, UPON DISASSEMBLY THE COMPONENTS WERE DISCOVERED TO BE COVERED IN RUST-COLORED DEBRIS AND THE O-RING SEAL WAS SEVERELY DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16356764 ↗
• MalfunctionFeb 10, 2023Break; Corroded; Failure to Advance; Break; Corroded; Failure to Advance

  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 TESTING. ADDITIONALLY, UPON INITIAL DISASSEMBLY THE ROLLING ELEMENTS WERE FOUND TO HAVE RUST-COLORED DEBRIS AND THE DRIVE PIN WAS OBSERVED TO BE BROKEN. THE MAGNET WAS ALSO OBSERVED TO HAVE RUST-COLORED DISCOLORATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16354406 ↗
• MalfunctionOct 27, 2022Mechanical 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. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING. UPON DISASSEMBLY OF THE ROD, DEBRIS WAS FOUND IN THE PIN HOUSING. 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 15681258 ↗
• MalfunctionOct 27, 2022Break; Corroded; Mechanical Jam; Break; 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 GALLING AND CORROSION. UPON DISASSEMBLY OF THE ROD A FRACTURED LOCKING PIN WAS FOUND ALONG WITH DEBRIS FOUND IN THE HOUSING BODY. 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 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681181 ↗
• MalfunctionJul 11, 2022Break; Mechanical Jam; Break; Mechanical Jam

  THE DEVICE WAS RETURNED FOR INVESTIGATION AS IT WAS SUSPECTED TO NOT BE ABLE TO DISTRACT. THERE WERE NO ADVERSE PATIENT EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982017 ↗
• MalfunctionJun 23, 2022Corroded; Degraded; Mechanical Jam; Naturally Worn; Scratched Material; Corroded; Degraded; 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 CORROSION ON THE ROD. ADDITIONALLY, WEAR, SCRATCHES, AND OTHER SURFACE DAMAGE WAS NOTED AND THE ROD WAS UNABLE TO BE DISTRACTED. 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. REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 14793105 ↗
• MalfunctionJun 22, 2022Corroded; Structural Problem; Mechanical Jam; Naturally Worn; Scratched Material; Corroded; Structural Problem; Mechanical Jam; Naturally Worn; Scratched Material

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO LOSS OF EXTENSION. DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THERE WAS WEAR, CORROSION AND OTHER SURFACE DAMAGE. ADDITIONALLY, DEBRIS WAS FOUND INSIDE THE ROD AND IT WAS JAMMED. THERE WAS NO FURTHER REPORTED PATIENT IMPACT AND NO PATIENT OR USER INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14779429 ↗
• MalfunctionJun 8, 2022Corroded; Dent in Material; Mechanical Jam; Naturally Worn; Scratched Material; Corroded; Dent in Material; 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 CORROSION ON THE ROD AND THE ROD WOULD NOT DISTRACT. ADDITIONALLY, WEAR, SCRATCHES, AND OTHER SURFACE DAMAGE WERE NOTED. IT WAS REPORTED THAT THE ROD WAS REMOVED AFTER THE FAILURE OF UNKNOWN FIXATION DEVICES. THERE WAS NO FURTHER REPORTED PATIENT IMPACT AND NO PATIENT OR USER INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629707 ↗
• MalfunctionJul 8, 2021Corroded; Fracture; Retraction Problem; Corroded; Fracture; Retraction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139780 ↗
• MalfunctionJul 8, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO END OF GROWTH. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD EVIDENCE GALLING. ADDITIONALLY IT WAS REPORTED THAT THE ROD WAS UNABLE TO BE RETRACTED.

  Patient problems: Failure of Implant

  MAUDE report 12136536 ↗
• MalfunctionJul 7, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC GALLING AND CORROSION WAS OBSERVED ON THE ROD. ADDITIONALLY THE ROD WAS UNABLE TO BE RETRACTED.

  Patient problems: Failure of Implant

  MAUDE report 12131415 ↗
• MalfunctionJul 6, 2021Mechanical Jam; Mechanical Jam

  N/A.

  Patient problems: Failure of Implant

  MAUDE report 12124352 ↗
• 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 12105040 ↗
• InjuryJul 1, 2021Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD NOT LENGTHENING. DURING A REVIEW OF INVESTIGATION FINDINGS FROM THE (B)(6), IT WAS IDENTIFIED THAT THE ROD WAS UNABLE TO RETRACT AND THERE WAS EVIDENCE OF CORROSION AND DISCOLORATION.

  Patient problems: Failure of Implant

  MAUDE report 12105013 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO A BROKEN ROD. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD SURFACE WEAR, MINOR GALLING, MINOR CORROSION, SCRATCHING DISCOLORATION AND MECHANICAL DAMAGE. ADDITIONALLY FORCE TESTING WAS UNABLE TO BE PERFORMED AS IT WAS IMPOSSIBLE TO RETRACT THE ROD. NO PATIENT HARM WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12100581 ↗
• MalfunctionFeb 18, 2021Unstable; Unstable

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE IS PLANNED ON AN UNKNOWN DATE. AS PER THE REPORTER, DURING THE POST-OP FOLLOW UP APPOINTMENT IT WAS NOTED THAT THE PROXIMAL HOOK PULLED OUT AGAIN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11346962 ↗