MAGEC® Spinal Bracing and Distraction System MS1-4570RRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00812258026349), received between Apr 10, 2020 and Apr 13, 2022 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 reports).

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.

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.

• MalfunctionApr 13, 2022Mechanical Problem; Mechanical Problem

  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 14104349 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H10.

  Patient problems: Bacterial Infection; Burning Sensation; Inflammation; Localized Skin Lesion; Metal Related Pathology; Necrosis; Purulent Discharge; Skin Discoloration

  MAUDE report 12691958 ↗
• MalfunctionJul 27, 2021Fracture; Fracture

  INFORMATION WAS RECEIVED THAT THE ROD WAS FRACTURED ON THE DISTAL END. NO PATIENT HARM WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12232222 ↗
• MalfunctionJul 1, 2021Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT AN EXPLANT PROCEDURE WAS PERFORMED SINCE THE ROD WAS FULLY EXTENDED. DURING A REVIEW OF INVESTIGATION FINDINGS FROM THE(B)(6), IT WAS IDENTIFIED THAT THE ROD WAS UNABLE TO DISTRACT AND THERE WAS EVIDENCE OF CORROSION/DISCOLORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105030 ↗
• InjuryJul 1, 2021Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD PULLING OUT. DURING A REVIEW OF INVESTIGATION FINDINGS FROM THE (B)(6), IT WAS IDENTIFIED THAT THE ROD WAS UNABLE TO RETRACT AND EXHIBITED CORROSION/DISCOLORATION.

  Patient problems: Failure of Implant

  MAUDE report 12104989 ↗
• MalfunctionApr 13, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  N/A.

  Patient problems: Failure of Implant

  MAUDE report 11660828 ↗
• InjuryNov 19, 2020Adverse 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) 2020. AS PER THE REPORTER THE PATIENT WAS FEBRILE POST-OP AND WAS FOUND TO HAVE PURULENCE THORACIC WOUND DEHISCENCE FOUND AT THE EXPANSION END OF THE ROD. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAD A CULTURE AND IMMUNODEFICIENCY WORK UP.

  Patient problems: Fever; Wound Dehiscence

  MAUDE report 10872368 ↗
• InjurySep 19, 2020Corroded; Mechanical Problem; Corroded; Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10557801 ↗
• MalfunctionApr 23, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. DURING A REVIEW OF INVESTIGATION FINDINGS FROM (B)(6) IT WAS IDENTIFIED THAT THE ROD HAD A PIN FAILURE. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9992602 ↗
• InjuryApr 10, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 FOR AN UNKNOWN REASON. AS PER THE REPORTER DURING SERVICING IT WAS IDENTIFIED THAT THE ROD HAS A COMPROMISED O-RING.

  Patient problems: Failure of Implant

  MAUDE report 9950802 ↗