MAGEC® Spinal Bracing and Distraction System RA002-5555SLR70Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00856719002169), received between Mar 13, 2020 and Jun 16, 2023 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Defective Device” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2023Mechanical Jam; 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 ON THE ROD. IT WAS REPORTED THAT THE ROD WAS REMOVED DUE TO THE PATIENT GRADUATION TO POSTERIOR SPINAL 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 17148834 ↗
• 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 EXERTED 35.3 LBF DURING FORCE TESTING. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS SOME GALLING AND CORROSION ON THE ROD. THE REASON FOR REMOVAL WAS DUE TO CRANKSHAFT PHENOMENON; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17004409 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED FOR THE REMOVAL THE MAGEC ROD AND CONVERSION TO A DEFINITIVE FUSION. AS PER THE REPORTER, THERE WERE A LOT OF BLACK STAINS IN THE TISSUE WHERE THE RODS HAD BEEN LENGTHENING. THERE WAS NO INFECTION OR NECROSIS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. REPORT 2 OF 2.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15106019 ↗
• MalfunctionJun 22, 2022Corroded; Mechanical Jam; Naturally Worn; Scratched Material; Corroded; 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 DISCOLORATION ON THE ROD, AND IT WAS JAMMED. ADDITIONALLY, WEAR, CORROSION, SCRATCHES, AND OTHER SURFACE DAMAGE WERE 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.

  Patient problems: Failure of Implant

  MAUDE report 14780445 ↗
• 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 GALLING. ADDITIONALLY, IT WAS REPORTED THAT THE ROD WAS UNABLE TO BE RETRACTED.

  Patient problems: Insufficient Information

  MAUDE report 12144449 ↗
• MalfunctionJul 7, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 12131966 ↗
• MalfunctionDec 29, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED 38 MONTHS AFTER BEING IMPLANTED. AS PER THE REPORTER THE ROD FAILED TO LENGTHEN. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD FUNCTIONED AS INTENDED.

  Patient problems: Failure of Implant

  MAUDE report 11092274 ↗
• MalfunctionOct 19, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, THE ROD WAS UNABLE TO LENGTHEN.

  Patient problems: Failure of Implant

  MAUDE report 10701960 ↗
• MalfunctionSep 4, 2020Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE ROD FAILED TO EXTEND.

  Patient problems: Failure of Implant

  MAUDE report 10497445 ↗
• InjuryMay 3, 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 DRIVE PIN WAS BROKEN AND THE O-RING SEAL HAD SNAPPED.

  Patient problems: Failure of Implant

  MAUDE report 10019783 ↗
• InjuryApr 24, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD HAD A PIN FAILURE. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9995624 ↗
• InjuryApr 12, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 FOR AN UNKNOWN REASON. AS PER THE REPORTER DURING SERVICE IT WAS IDENTIFIED THAT THERE WAS A PIN FRACTURE AND A LARGE AMOUNT OF DEBRIS IN THE HOUSING TUBE.

  Patient problems: Failure of Implant

  MAUDE report 9951857 ↗
• MalfunctionApr 11, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A PIN FRACTURE AND A COMPROMISED O-RING. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9951669 ↗
• MalfunctionApr 10, 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 (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A PIN FRACTURE AND A COMPROMISED O-RING. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9950934 ↗
• MalfunctionMar 13, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER THE REPORTER, THE ROD WAS REMOVED FOR COMPLETE EXTENSION. X-RAY IMAGES REVEALED A BROKEN PIN.

  Patient problems: Failure of Implant

  MAUDE report 9830176 ↗