Universal Neuro 3 56-15934Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 37613327090735), received between Jun 22, 2018 and Oct 25, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 25, 2021Migration; Migration

  IT WAS REPORTED THAT THE SCREWS THAT WERE IMPLANTED, HAD MIGRATED AND SEPARATED FROM THE IMPLANT THERE WAS A REVISION SURGERY PERFORMED TO ADJUST THE SCREWS AND PLATE. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12690883 ↗
• InjuryAug 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY PERFORMED TO REMOVE A BROKEN DRILL BIT FROM THE PATIENT. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12333121 ↗
• InjuryJun 19, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A PATIENT DEVELOPED A POST-SURGICAL INFECTION AFTER A PROCEDURE WITH AN IMPLANT. THERE ARE NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 10173607 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ORBITAL FLOOR PLATE NEEDED TO BE REMOVED BECAUSE THE PATIENT BEGAN EXPERIENCING DOUBLE VISION.

  Patient problems: Visual Impairment

  MAUDE report 7629640 ↗