MAGEC® Spinal Bracing and Distraction System RA002-5555SLRRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00856719002114), received between Aug 28, 2019 and Jun 16, 2023 — classified as 21 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (26 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 81 reports, in the reporter's own words as published by the FDA.

• 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 17148913 ↗
• MalfunctionJun 16, 2023Mechanical Jam; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD WOULD NOT CONFORM FOR FORCE TESTING. 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 17145220 ↗
• MalfunctionJun 16, 2023Corroded; Corroded

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD EXERTED 50.3 LBF DURING FORCE TESTING. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145108 ↗
• MalfunctionJun 16, 2023Corroded; Failure to Advance; Mechanical Jam; Corroded; Failure to Advance; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD EXERTED 12 LBF DURING FORCE TESTING. 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 17145053 ↗
• 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 17144776 ↗
• MalfunctionJun 16, 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. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING 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 17144584 ↗
• 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 17144340 ↗
• MalfunctionJun 16, 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. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING 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 17144300 ↗
• MalfunctionJun 1, 2023Corroded; Migration or Expulsion of Device; Mechanical Jam; Corroded; Migration or Expulsion of Device; Mechanical Jam

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17039178 ↗
• 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 GALLING AND CORROSION. 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 17039066 ↗
• 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 GALLING AND CORROSION. 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 17038916 ↗
• 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 PASSED FORCE TESTING. 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 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 17034789 ↗
• MalfunctionMay 31, 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. 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 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 17032533 ↗
• 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 CORROSION. UPON DISASSEMBLY OF THE ROD, THE RADIAL BEARING WAS FOUND TO BE DAMAGED. 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 17014941 ↗
• 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 CORROSION. UPON DISASSEMBLY OF THE ROD, THE RADIAL BEARING WAS FOUND TO BE DAMAGED. 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 17014902 ↗
• MalfunctionMay 26, 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 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. UPON DISASSEMBLY, THERE WAS DEBRIS FOUND IN THE ROD. 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 17011534 ↗
• 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, 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. UPON DISASSEMBLY, THERE WAS CLEAR EVIDENCE OF PIN FRACTURE. 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 17010851 ↗
• MalfunctionMay 25, 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 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 17007581 ↗
• MalfunctionMay 25, 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 ROD. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17007265 ↗
• MalfunctionMay 25, 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 EXTEND AND FORCE TESTING WAS UNABLE TO BE PERFORMED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION ON THE ROD. UPON DISASSEMBLY OF THE ROD THE TELESCOPIC ROD AND INTERNAL SCREW WERE FOUND TO BE STUCK AND THERE WAS BLACK/YELLOW STAINING AND METALLIC DEBRIS AROUND THE MAGNET AREA. THE REASON FOR REMOVAL IS UNKNOWN; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17004293 ↗
• MalfunctionFeb 15, 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, THE ROD WAS TESTED IN A JIG WITH AN EXTERNAL REMOTE CONTROLLER (ERC), AND IT EXERTED NO FORCE. ADDITIONALLY, THE RADIAL BEARING WAS SEIZED TO THE MAGNET. THE O-RING WAS VERY BADLY DAMAGED. ONLY TWO PIECES WERE FOUND INSIDE THE GROOVE AND NO OTHER PIECES WERE ABLE TO BE RETRIEVED.

  Patient problems: Failure of Implant

  MAUDE report 16381102 ↗
• 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, WHEN TESTED WITH THE EXTERNAL REMOTE CONTROLLER (ERC), THAT THE ROD EXERTED NO FORCE. THE ROD WAS NOT ABLE TO BE DISASSEMBLED FOR FURTHER INVESTIGATION AS THE OUTER CASING WAS SEIZED TO THE MAGNET AND EXTENDING BAR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16381012 ↗
• MalfunctionFeb 15, 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, THE ROD EXERTED NO FORCE DURING TESTING. ADDITIONALLY, THE RADIAL BEARING COULD ROTATE, BUT THE LEADSCREW WAS SEIZED INSIDE THE EXTENDING BAR. THE O-RING SEAL WAS ALSO NOTED TO BE SEVERELY DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16380093 ↗
• 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 EXERTED NO FORCE DURING TESTING. THE ROD WAS UNABLE TO BE FULLY DISASSEMBLED AS IT WAS SEIZED TOGETHER, THEREFORE, EXAMINATION OF THE DRIVE PIN AND INTERNAL COMPONENTS WAS NOT POSSIBLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16379973 ↗
• 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 EXERTED NO FORCE DURING TESTING. ADDITIONALLY, THE INTERNAL COMPONENTS WERE SEIZED WITHIN THE OUTER CASING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16379579 ↗