MAGEC® Spinal Bracing and Distraction System MS1-5590RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812258026325), received between Nov 5, 2019 and Aug 3, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Break; Break

  INFORMATION WAS RECEIVED THAT ROD FRACTURED AND LOOKS LIKE IT CAME "UNHINGED." THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 17451581 ↗
• MalfunctionApr 19, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE ROD FAILED TO DISTRACT. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14145388 ↗
• MalfunctionJul 1, 2021No Apparent Adverse Event; No Apparent Adverse Event

  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 EXPERIENCED A PIN BREAK, SURFACE WEAR, GALLING, SCRATCHING, DISCOLORATION, AND MECHANICAL DAMAGE. ADDITIONALLY, FORCE TESTING WAS NOT PERFORMED AS IT WAS IMPOSSIBLE TO RETRACT THE ROD. NO PATIENT HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12101102 ↗
• 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 O-RING WAS DAMAGED.

  Patient problems: Failure of Implant

  MAUDE report 9950973 ↗
• InjuryNov 25, 2019Defective Device; Defective Device

  THIS REPORT HAS BEEN UPDATED TO INCLUDE INVESTIGATION FINDINGS.

  Patient problems: Failure of Implant

  MAUDE report 9370964 ↗
• InjuryNov 5, 2019Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A PATIENT UNDERWENT A POSTERIOR SPINAL INSTRUMENTATION IMPLANT APPROXIMATELY THREE YEARS AGO. THE IMPLANTS WERE STRYKER SCREWS BUT MAGEC RODS ALONG WITH BONE GRAFTING POSTERIOR ARTHRODESIS T2, T3, T4 AND ALSO L1 AND L2. AFTER TWO ADJUSTMENTS OF THE RODS, THE PATIENT HAD THE RODS REMOVED DUE TO THE FAILURE OF THE RODS LENGTHENING TRANSCUTANEOUSLY. THIS PATIENT UNDERWENT REMOVAL OF THE RODS LAST MONTH AND HAD REPLACEMENT WITH SOLERA SCREWS, CONNECTORS, AND RODS. NO COMPLICATIONS AND PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT CONCERNS.

  Patient problems: Failure of Implant

  MAUDE report 9279366 ↗