MAGEC® Spinal Bracing and Distraction System MS1-5570SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812258026356), received between Sep 28, 2021 and Feb 26, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT DURING THE PATIENT'S EXPANSION APPOINTMENT IT WAS NOTED THAT THERE WAS LITTLE TO NO EXPANSION OF THE ROD AND THE ROD BECAME SO PROMINENT IT APPEARED IT WAS GOING TO POP OUT OF THE SKIN. THE HARDWARE HAD BECOME PROMINENT WHICH CAUSED SKIN TENTING AND WAS BLANCHING THE PATIENT'S SKIN IN THE BACK REGION. ADDITIONALLY, THE PATIENT BEGAN EXPERIENCING INCREASED LAXITY IN THEIR HANDS AND WRIST. THE PATIENT EXPERIENCED PAIN IN THE MIDBACK AND THEIR SKIN HAD BECOME OPAQUE. THERE WAS HETEROTROPIC OSSIFICATION PARTIALLY SURROUNDING THE RIGHT ROD FROM T8 TO T12 WITH GREATER THAN 180 DEGREE INVOLVEMENT AROUND THE T9 TO T11 LEVEL. DEGENERATIVE CHANGES IN THE FACETS WITHOUT OSSEOUS FUSION OF L3-L4 AND OSSEOUS FUSION OF THE BILATERAL L2-L3 FACETS. THE PATIENT WAS FOUND TO HAVE ROD PULL OUT PROXIMALLY AND WAS EXPERIENCING POOR LUNG FUNCTION. THE PROXIMAL SCREWS IN THE ROD HAD LITTLE TO NO PURCHASE AND THE PATIENT'S SPINE HAD AUTOFUSED FROM T4 ALL THE WAY UP TO THE C7 LEVEL. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE RODS. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain; Skin Discoloration

  MAUDE report 13614936 ↗
• MalfunctionFeb 26, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT AFTER THE INITIAL SURGERY, THE RODS ONLY LENGTHENED ONCE AND THE PATIENT EXPERIENCED PAIN IN THE LOWER BACK. DURING A FOLLOW UP VISIT, IT WAS NOTED THAT THE MAGEC ROD HAD BECOME PROMINENT IN THE UPPER BACK. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS INCREASED LUCENCY SURROUNDING THE L3 AND L4 PEDICLE SCREWS THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UPPER BILATERAL LAMINAR HOOKS DISLODGING. THE PATIENT'S SPINE WAS FUSED FROM T2 TO T4 AND ALLOGRAFT WAS PLACED. THE SURGEON REPLACED THE PROXIMAL HOOKS WITH PEDICLE SCREWS TO BETTER HOLD THE ROD. THERE WERE NO PATIENT INTRAOPERATIVE COMPLICATIONS. TWO RODS WERE INVOLVED IN THE COMPLAINT. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13608188 ↗
• InjuryFeb 26, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE RODS ONLY LENGTHENED ONCE AND THE PATIENT EXPERIENCED PAIN IN THE LOWER BACK STARTING (B)(6) 2016. ON (B)(6) 2016, IT WAS NOTED THAT THE MAGEC ROD HAD BECOME PROMINENT IN THE UPPER BACK. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016 DUE TO UPPER BILATERAL LAMINAR HOOKS DISLODGING. THE PATIENT'S SPINE WAS FUSED FROM T2 TO T4 AND ALLOGRAFT WAS PLACED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.

  Patient problems: Pain

  MAUDE report 13608126 ↗
• InjurySep 28, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT A REVISION WAS PERFORMED DUE TO THE ROD NOT DISTRACTING. THE ROD WAS REPLACED WITH NO FURTHER ADVERSE IMPACT TO THE PATIENT. REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 12544878 ↗