MAGEC® Spinal Bracing and Distraction System MC2-6090SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00812258022709), received between Oct 2, 2019 and Jun 16, 2023 — classified as 1 injury, 9 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 1, 2022Class IIOpen, Classified

   During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.

   Z-0559-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2023Break; Corroded; Mechanical Jam; Break; 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 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 17148877 ↗
• 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 WOULD NOT EXTEND AND FORCE TESTING WAS UNABLE TO BE COMPLETED. DURING DISASSEMBLY THE RADIAL BEARING WAS FOUND TO BE 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 17032014 ↗
• MalfunctionMay 26, 2023Mechanical Jam; Mechanical Jam

  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 GALLING. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17014946 ↗
• MalfunctionOct 29, 2022Failure to Advance; Mechanical Jam; Failure to Advance; 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, DURING SURFACE GRADING GALLING WAS NOTED. THE REASON FOR REMOVAL IS UNKNOWN; THERE WAS INSUFFICIENT INFORMATION TO KNOW IF THERE WAS AN ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15696357 ↗
• 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 OF GALLING.

  Patient problems: Insufficient Information

  MAUDE report 12144387 ↗
• MalfunctionJun 3, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD NOT LENGTHENING. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11935661 ↗
• InjuryDec 17, 2020Migration; Migration

  A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Failure of Implant

  MAUDE report 11033833 ↗
• 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 THE ROD HAD A PIN FRACTURE AND A LARGE AMOUNT OF DEBRIS IN HOUSING TUBE. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9951843 ↗
• MalfunctionFeb 28, 2020Migration; Migration

  INFORMATION WAS RECEIVED THAT THE END CAP ON THE ROD WAS DISLODGED. AS PER REPORTER, A REVISION PROCEDURE HAS NOT BEEN PERFORMED BUT IS PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 9771983 ↗
• MalfunctionOct 2, 2019Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT THE END CAP HAD BECOME DISENGAGED FROM THE ROD. AS PER REPORTER, NO REVISION PROCEDURE WILL BE CONDUCTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 9145665 ↗