MAGEC MC2-5090RRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887517834034), received between Apr 23, 2020 and Jun 16, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K171791); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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 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 AS WELL AS THE PATIENT EXPERIENCING PAIN; THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17148890 ↗
• MalfunctionMay 31, 2023Break; Corroded; Mechanical Jam; Break; Corroded; Mechanical Jam

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17032283 ↗
• MalfunctionJul 11, 2022Mechanical Jam; Mechanical Jam

  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 14982169 ↗
• MalfunctionJun 22, 2022Naturally Worn; Scratched Material; Physical Resistance/Sticking; Naturally Worn; Scratched Material; 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 DISCOLORATION ON THE ROD. ADDITIONALLY, WEAR, GALLING, SCRATCHING, 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 14779994 ↗
• InjuryJun 8, 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 A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD FAILING TO DISTRACT. DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THE ROD UNABLE TO DISTRACT AND FOUND CORROSION. ADDITIONALLY, DISCOLORATION, 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 14629754 ↗
• MalfunctionNov 3, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12745349 ↗
• MalfunctionOct 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED THAT THE ROD'S END CAP DISENGAGED. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12584641 ↗
• MalfunctionSep 22, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED THAT THE ROD HAD AN END CAP FAILURE. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12513295 ↗
• MalfunctionMar 8, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED THAT X-RAYS NOTED THE END CAP HAD BECOME DISPLACED. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS BLACKENING OF THE TISSUE. THERE IS NO REVISION PROCEDURE PLANNED AT THIS TIME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Skin Discoloration

  MAUDE report 11439761 ↗
• MalfunctionMar 1, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO THE END CAP BEING SEPARATED. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(4) IT WAS IDENTIFIED THAT THERE WAS NO PROBLEM FOUND.

  Patient problems: Failure of Implant

  MAUDE report 11397118 ↗
• MalfunctionMar 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE ROD WAS NOT LENGTHENING. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THE ROD WAS UNABLE TO BE RETRACTED.

  Patient problems: Failure of Implant

  MAUDE report 11397099 ↗
• MalfunctionApr 23, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT PRIOR TO INSERTION, THE ROD WAS TESTED AND IT WAS IDENTIFIED THAT THE ROD WAS NOT DISTRACTING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9993180 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171791. One submission often covers many models, so check the product and lot details in each record.

• Z-1657-2025 · Apr 3, 2025 · Open, Classified
  MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
• Z-1898-2020 · Feb 13, 2020 · Terminated
  NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVa