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

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00812258022617), received between Jul 30, 2020 and Jun 8, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Migration” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2022Fracture; Material Fragmentation; Naturally Worn; Scratched Material; Fracture; Material Fragmentation; 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 BEARING MECHANISM TO BE FRACTURED AND OUT OF POSITION, AND METALLIC FRAGMENTS AROUND THE LEAD SCREW. ADDITIONALLY, WEAR, SCRATCHES, DISCOLORATION, O-RING DAMAGE 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 1 OF 2.

  Patient problems: Pain

  MAUDE report 14629729 ↗
• MalfunctionMar 1, 2021Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE DUE TO A BROKEN ROD. DURING A REVIEW OF INVESTIGATION FINDINGS FROM LIRC IT WAS IDENTIFIED THAT THERE WAS NO PROBLEM FOUND.

  Patient problems: Failure of Implant

  MAUDE report 11397104 ↗
• MalfunctionJan 11, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED THAT X-RAY IMAGED REVEALED SEPARATION OF ACTUATOR AND END CAP. THERE WAS NO PATIENT INJURY REPORTED. NO REVISION SURGERY IS PLANNED AS THE SURGEON WANTS TO OBSERVE THE FUNCTIONALITY OF THE ROD.

  Patient problems: Failure of Implant

  MAUDE report 11151203 ↗
• MalfunctionDec 30, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 FOR A FINAL FUSION. THERE WAS NO PATIENT INJURY REPORTED. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) THE ROD FAILED TO DISTRACT.

  Patient problems: Failure of Implant

  MAUDE report 11098820 ↗
• MalfunctionDec 29, 2020Migration; Migration

  INFORMATION WAS RECEIVED THAT X-RAY IMAGES REVEALED THAT THE END CAP HAD DISENGAGED. IT IS UNKNOWN IF A REVISION HAS BEEN PLANNED AT THIS TIME. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11092296 ↗
• MalfunctionOct 22, 2020Migration; Migration

  INFORMATION WAS RECEIVED THAT X-RAY IMAGING REVEALED THAT THE ACTUATOR END CAP OFF THE OFFSET ROD CAME LOOSE. THERE WAS NO PATIENT INJURY REPORTED. NO REVISION PROCEDURE IS PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 10722951 ↗
• MalfunctionOct 9, 2020Migration; Migration

  SEE UPDATED INFORMATION IN H2, H3, H6 AND H10.

  Patient problems: Failure of Implant

  MAUDE report 10659675 ↗
• MalfunctionJul 30, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED THAT X-RAY IMAGES REVEALED THAT THE END CAP HAD DISENGAGED. NO REVISION PROCEDURE IS PLANNED AS THE ROD IS STILL IN-SITU. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10348385 ↗