Universal Neuro 3 56-15034Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 37613327090711), received between Sep 28, 2018 and Apr 21, 2022 — classified as 2 malfunctions.

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

• MalfunctionApr 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SCREWING INTO PLACE, THE SCREW HEADS BROKE OFF AND SURGEON LEFT THE SCREW SHAFT IN THE BONE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14174800 ↗
• MalfunctionSep 28, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE SCREW HEAD BROKE OFF DURING INSERTION. THE BODY OF THE SCREW WAS LEFT IN THE PATIENT. THERE WAS NO ADVERSE CONSEQUENCE NOR DELAY OF SURGERY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920223 ↗