MAGEC MC2-5070RRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887517834010), received between Nov 11, 2019 and May 26, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Break; Corroded; Mechanical Jam; Break; Corroded; Mechanical Jam

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED AND REPORTED THAT DURING EXAMINATION, FORCE TESTING WAS UNABLE TO BE PERFORMED. ADDITIONALLY, IT WAS NOTED DURING SURFACE DAMAGE GRADING THAT THERE WAS GALLING AND CORROSION. HIGH ENERGY X-RAY EVALUATION SHOWED EVIDENCE OF INTERNAL SCREW FRACTURE. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17015004 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT DURING REMOVAL FOR DEFINITIVE FUSION AFTER TREATMENT GOALS WERE ACHIEVED, IT WAS NOTED THERE WAS "METALLOSIS" PRESENT.

  Patient problems: Metal Related Pathology

  MAUDE report 16513658 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THERE WERE SIGNS OF METALLOSIS. THE ROD HAS BEEN EXPLANTED AND REPLACED WITH A TRADITIONAL GROWING ROD. REPORT 2 OF 2.

  Patient problems: Metal Related Pathology

  MAUDE report 15259556 ↗
• MalfunctionJul 13, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE ROD WAS NOT LENGTHENING. NO PATIENT HARM WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12161111 ↗
• MalfunctionJun 29, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT A ROD FAILED TO DISTRACT SUBSEQUENT TO THE INITIAL DISTRACTION SESSION. NO PATIENT IMPACT WAS REPORTED BUT A REVISION SURGERY IS ANTICIPATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 12087612 ↗
• MalfunctionMar 1, 2021Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 11397112 ↗
• MalfunctionDec 9, 2020Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. AS PER THE REPORTER, THE ROD WAS BROKEN. REPORTEDLY, WHEN THE ROD WAS EXPLANTED IT WAS NOTICEABLY BROKEN AT THE PART WHERE THE ROD COMES OUT WHEN DISTRACTING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10979237 ↗
• InjuryMar 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 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9831128 ↗
• InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER REPORTER THE PATIENT WAS EXPERIENCING POSTOPERATIVE INFECTION, FEVER, AND SWELLING.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 9307530 ↗

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