Universal Neuro 3 56-15933Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 37613327090759), received between Mar 14, 2023 and Mar 14, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD POST OPERATIVE IRRITATION. SURGEON REVIEWED A POST OP SCAN WHICH SHOWED THE PLATE AND SCREW WERE LOOSE, WHICH COULD RESULT IN DAMAGE OF BONE, TISSUE OR STRUCTURES, REQUIRING SURGERY TO PREVENT PERMANENT IMPAIRMENT. THERE WAS A REVISION SURGERY AND DEVICES WERE REMOVED AND FIXATED. HE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Failure of Implant

  MAUDE report 16537274 ↗