MAGEC® Spinal Bracing and Distraction System MC2-4570SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00812258022600), received between Oct 28, 2019 and Aug 14, 2024 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Corroded” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Failure to Advance; Failure to Advance

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD FAILED FORCE TESTING. THERE WAS DEBRIS SEEN IN THE ROD, ALTHOUGH IT WAS ONLY PARTIALLY DISASSEMBLED. ADDITIONALLY, THE LEADSCREW WAS FOUND TO BE SEIZED WITHIN THE EXTENDING BAR. IT IS UNKNOWN WHY THE ROD WAS REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19983655 ↗
• MalfunctionAug 14, 2024Failure to Advance; Failure to Advance

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, THE ROD FAILED FORCE TESTING. THE ROD WAS DISASSEMBLED AND SUBSTANTIAL DEBRIS WAS SEEN AROUND THE LEADSCREW, THE RADIAL BEARING, AND THE EXTENDING BAR. ADDITIONALLY THE LEADSCREW WAS FOUND TO BE SEIZED WITHIN THE EXTENDING BAR. IT IS UNKNOWN WHY THE ROD WAS REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19983552 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THE PATIENT HAD AN INFECTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16460487 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THE PATIENT HAD AN INFECTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16460484 ↗
• MalfunctionOct 28, 2022Break; Corroded; Break; Corroded

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING SURFACE DAMAGE GRADING THAT THERE WAS CORROSION OBSERVED ON THE TELESCOPIC ROD. THE REASON FOR REMOVAL IS REPORTEDLY DUE TO ROD FRACTURE. 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 15692416 ↗
• InjuryJun 8, 2022Mechanical Jam; Naturally Worn; Scratched Material; 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 UNEXPECTED PAIN. DURING EXAMINATION OF THE ROD, THE RETRIEVAL CENTER FOUND THE ROD WOULD NOT DISTRACT. ADDITIONALLY, DISCOLORATION, WEAR, 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: Pain

  MAUDE report 14629734 ↗
• MalfunctionJun 8, 2022Dent in Material; Naturally Worn; Scratched Material; Dent in Material; 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. ADDITIONALLY, WEAR, SCRATCHES, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629687 ↗
• MalfunctionApr 18, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE ROD WOULDN'T LENGTHEN DURING TESTING. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 14137445 ↗
• MalfunctionAug 12, 2021Corroded; Corroded

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315556 ↗
• MalfunctionAug 12, 2021Corroded; Corroded

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315381 ↗
• MalfunctionJul 1, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED AS THERE WAS A ROD PULL OUT. DURING A REVIEW OF INVESTIGATION FINDINGS FROM THE (B)(6), IT WAS IDENTIFIED THAT THE ROD WAS FOUND TO HAVE SURFACE SCRATCHING, WEAR, GALLING AND MECHANICAL DAMAGE. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12100041 ↗
• MalfunctionSep 3, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED THAT AT THE FIRST LENGTHENING, X-RAY IMAGES REVEALED THAT THERE WAS MIGRATION OF THE END CAP FROM THE ACTUATOR HOUSING. THE PATENT WILL BE MONITORED AT FUTURE LENGTHENING CLINICS.

  Patient problems: Failure of Implant

  MAUDE report 10492098 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, THE PATIENT DEVELOPED AN INFECTION AND THE SURGEON DECIDED TO REMOVE THE ROD. THERE WAS NO ALLEGED DEVICE MALFUNCTION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 9908668 ↗
• MalfunctionOct 28, 2019Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  RECEIVED INFORMATION STATING THE REVISION PROCEDURE WAS EXTENDED DUE TO SURGICAL COMPLICATIONS. PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) INSTEAD OF GENERAL WARD.

  Patient problems: Blood Loss; Failure of Implant; Low Oxygen Saturation

  MAUDE report 9246070 ↗