Universal Neuro 3 56-15935Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 37613327090742), received between Sep 14, 2018 and Jul 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Device Handling Problem

  It was reported that during cranial closure following tumor removal, a screwdriver slipped through a burr hole cover while reinserting a self drilling screw, resulting in intracranial bleeding. The bone flap was removed to identify and manage the source of bleeding. The patient developed a brain hematoma, underwent CT MRI imaging, was admitted to the ICU, and the original bone flap was lost.

  Patient problems: Dysphasia; Hematoma

  MAUDE report 50081497 ↗
• InjurySep 14, 2018Device Slipped

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT SCREWS THAT WERE USED TO FIXATE A PLATE DURING A CRANIOPLASTY HAD COME LOOSE. A REVISION SURGERY WAS PREFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 7877207 ↗