MAGEC® Spinal Bracing and Distraction System RA002-4545SLR70Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00856719002145), received between Aug 28, 2019 and Jun 16, 2023 — classified as 13 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Defective Device” (15 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 31 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 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 17148813 ↗
• MalfunctionJun 1, 2023Break; Corroded; Break; Corroded

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT THE ROD PASSED FORCE TESTING. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS CORROSION. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO THE 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 17039295 ↗
• 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 DID NOT EXERT ANY FORCE DURING FORCE TESTING. 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 17031705 ↗
• MalfunctionMar 9, 2023Break; Break

  INFORMATION WAS RECEIVED THAT THERE WAS SLIGHT PISTONING OF THE ROD. THE ROD HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16513639 ↗
• MalfunctionMar 9, 2023Break; Break

  INFORMATION WAS RECEIVED THAT THERE WERE SIGNS OF PISTONING. THE ROD HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16513626 ↗
• MalfunctionFeb 15, 2023Structural Problem; Failure to Advance; Detachment of Device or Device Component; Physical Resistance/Sticking; Structural Problem; Failure to Advance; Detachment of Device or Device Component; 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 WAS FOUND OUT OF POSITION AND THE LEADSCREW WAS INSIDE THE EXTENDING BAR. THE O-RING SEAL WAS ALSO REPORTED TO BE BROKEN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16379838 ↗
• MalfunctionFeb 15, 2023Break; Structural Problem; Failure to Advance; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Structural Problem; Failure to Advance; Detachment of Device or Device Component; 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 DRIVE PIN WAS PROTRUDING AND BROKEN, THE RADIAL BEARING WAS OUT OF POSITION AND THE LEADSCREW WAS SEIZED INSIDE THE EXTENDING BAR. THE O-RING SEAL WAS VERY BADLY DAMAGED THAT THE MISSHAPEN ELEMENT OF THE O-RING SEAL WAS THE ONLY PART THAT COULD BE RETRIEVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16379665 ↗
• MalfunctionFeb 10, 2023Degraded; Structural Problem; Failure to Advance; Mechanical Jam; Degraded; Structural Problem; Failure to Advance; Mechanical Jam

  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, UPON INITIAL DISASSEMBLY THE RADIAL BEARING WAS NOTED TO BE ABLE TO ROTATE, HOWEVER, IT WAS JAMMED ON THE MAGNET AND HAD BUILD-UP OF MATERIAL. THE O-RING SEAL WAS REPORTED TO HAVE BEEN SNAPPED. FURTHER DISASSEMBLY WAS NOT POSSIBLE, THEREFORE, THE DRIVE PIN WAS UNABLE TO BE EXAMINED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16354314 ↗
• MalfunctionJun 23, 2022Corroded; Degraded; Naturally Worn; Scratched Material; Corroded; Degraded; 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, DISCOLORATION, AND OTHER SURFACE DAMAGE WAS NOTED. 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 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 14793164 ↗
• 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 WEAR, GALLING, CORROSION, SCRATCHING, DISCOLORATION AND OTHER SURFACE DAMAGE. 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 14779586 ↗
• MalfunctionApr 13, 2022Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE ROD WOULD NOT DISTRACT. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104317 ↗
• MalfunctionJul 8, 2021Corroded; Fracture; Retraction Problem; Corroded; Fracture; Retraction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139799 ↗
• MalfunctionJul 6, 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 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: Failure of Implant

  MAUDE report 12125002 ↗
• 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 AND DEBRIS, MINOR CORROSION, SCRATCHING, DISCOLORATION, AND MECHANICAL DAMAGE. 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 12100950 ↗
• MalfunctionSep 25, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE ROD WAS MALFUNCTIONING. AS PER THE SURGEON, THE PIN/MAGNET INTERFACE IS COMPROMISED. THERE WAS NO PATIENT INJURY REPORTED. THE PLAN IS FOR THE PATIENT TO BE FUSED AS SOON AS POSSIBLE.

  Patient problems: Failure of Implant

  MAUDE report 10587027 ↗
• MalfunctionSep 11, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A PIN FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 10521938 ↗
• MalfunctionSep 11, 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 LIRC IT WAS IDENTIFIED THAT THE DISTRACTION ROD WAS STUCK IN THE HOUSING TUBE, COLD WELDING BETWEEN THE HOUSING TUBE AND DISTRACTION ROAD AND A PIN FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 10521877 ↗
• InjuryApr 23, 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 NEWCASTLE IT WAS IDENTIFIED THAT THE ROD HAD FAILED TO DISTRACT. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9993695 ↗
• InjuryApr 14, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT THERE WAS A REVISION PROCEDURE PERFORMED ON (B)(6) 2019 FOR AN UNKNOWN REASON. AS PER THE REPORTER DURING SERVICE IT WAS IDENTIFIED THAT THERE WAS A BROKEN PIN AND O-RING SEAL HAD WORN FLAT.

  Patient problems: Failure of Implant

  MAUDE report 9959738 ↗
• InjuryApr 14, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014, FOR AN UNKNOWN REASON. AS PER THE REPORTER DURING SERVICE IT WAS IDENTIFIED THAT THE O-RING SEAL HAD WORN IN ONE AREA AND WAS PROTRUDING OUT OF THE CASING.

  Patient problems: Failure of Implant

  MAUDE report 9959087 ↗
• InjuryApr 13, 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 SERVICING A PIN BREAK WAS CONFIRMED AND A O-RING SEAL HAD WORN FLAT.

  Patient problems: Failure of Implant

  MAUDE report 9955929 ↗
• InjuryApr 13, 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 PIN WAS BROKEN, THE O-RING WAS WORN AND UNSEATED WITHIN THE OUTER CASING.

  Patient problems: Failure of Implant

  MAUDE report 9955922 ↗
• InjuryApr 12, 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 THERE WAS CLINICAL COLD WELDING AND DEBRIS IN HOUSING TUBE.

  Patient problems: Failure of Implant

  MAUDE report 9951920 ↗
• MalfunctionApr 12, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THERE WAS COLD-WELDING BETWEEN HOUSING TUBE AND DISTRACTION ROD. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9951835 ↗
• InjuryApr 11, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2017. AS PER THE REPORTER DURING SERVICING IT WAS IDENTIFIED THAT THE ROD HAD A COMPROMISED O-RING.

  Patient problems: Failure of Implant

  MAUDE report 9951742 ↗