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

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00812258026332), received between Aug 21, 2019 and Oct 31, 2022 — classified as 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2022Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED THAT REMOVAL PROCEDURE WAS PERFORMED. THERE WAS NO REPORTED MALFUNCTION OR SERIOUS INJURY REPORTED; HOWEVER, THE REMOVED ROD WAS RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. DURING THE COURSE OF THE DEVICE EVALUATION THE ROD WAS FOUND TO BE JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15701221 ↗
• MalfunctionMar 10, 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 13720996 ↗
• MalfunctionMar 8, 2022Mechanical Problem; Mechanical Problem

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

  Patient problems: Failure of Implant

  MAUDE report 13695943 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED A "SKIN ERUPTION" AND METAL REACTION. A CLEANSING AND DEBRIDEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE REACTION SEEMS TO BE DUE TO AN OILY SUBSTANCE FOUND ROUND THE TOP PORTION OF THE ACTUATOR OF THE ROD. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS DISCOLORATION OF THE SURROUNDING TISSUE.

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

  MAUDE report 12691591 ↗
• MalfunctionOct 6, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12586782 ↗
• MalfunctionOct 6, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12584662 ↗
• MalfunctionJun 14, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE SURGEON BELIEVING THAT THE RODS WERE NOT DEPLOYING DUE TO EXTENDED TIME BETWEEN DISTRACTIONS. NO PATIENT HARM WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11995933 ↗
• 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 10872388 ↗
• MalfunctionNov 4, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE ROD WAS NOT LENGTHENING WELL. THERE WAS NO PATIENT INJURY REPORTED AND IT IS UNKNOWN IF A REVISION PROCEDURE IS PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 10787193 ↗
• InjuryAug 17, 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 IMPLANTED WITH ONE COBALT ROD AND ONE MAGEC ROD. REPORTEDLY, THE SIDE WITH THE MAGEC ROD DEVELOPED AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10418249 ↗
• MalfunctionApr 27, 2020Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. BASED ON ENGINEERING REVIEW PERFORMED ON MARCH 10 2020, IT WAS IDENTIFIED THAT THE ROD HAD A COMPROMISED O-RING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10001561 ↗
• InjuryApr 27, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2017. AS PER THE REPORTER THE ROD WAS ONLY ABLE TO ACHIEVE MINIMAL DISTRACTION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10001152 ↗
• InjuryApr 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)(4) IT WAS IDENTIFIED THAT THE ROD HAD A COMPROMISED O-RING. NO OTHER INFORMATION IN RELATION TO PATIENT HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9993787 ↗
• 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 9950871 ↗
• InjuryAug 21, 2019Defective Device; Defective Device

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE. AS PER REPORTER IT IS UNKNOWN IF PRODUCT MAY OR MAY NOT HAVE REACHED TERMINAL DISTRACTION LENGTH.

  Patient problems: Failure of Implant

  MAUDE report 8918980 ↗
• InjuryAug 21, 2019Defective Device; Defective Device

  IT WAS REPORTED THE MAGEC RODS DID NOT LENGTHEN AFTER (B)(6) 2017. RODS WOULD NOT LENGTHEN WITH MANUAL DISTRACTOR AFTER REMOVAL DESPITE APPEARING NOT TO HAVE REACHED TERMINAL DISTRACTION LENGTH.

  Patient problems: Failure of Implant

  MAUDE report 8918941 ↗
• InjuryAug 21, 2019Defective Device; Defective Device

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE. AS PER REPORTER, THE RIGHT ROD WAS UNABLE TO LENGTHEN WITH THE MANUAL DISTRACTOR AFTER REMOVAL, DESPITE APPEARING TO NOT HAVE REACHED THE TERMINAL DISTRACTION LENGTH.

  Patient problems: Failure of Implant

  MAUDE report 8918920 ↗
• InjuryAug 21, 2019Defective Device; Defective Device

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE. AS PER REPORTER, IT IS UNKNOWN IF THE PRODUCT REACHED TERMINAL DISTRACTION LENGTH.

  Patient problems: Failure of Implant

  MAUDE report 8918902 ↗
• InjuryAug 21, 2019Defective Device; Defective Device

  AS PER REPORTER IT IS UNKNOWN IF PRODUCT MAY OR MAY NOT HAVE REACHED TERMINAL DISTRACTION LENGTH. PATIENT UNDERWENT A REVISION PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 8918887 ↗