UniVise 48590040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327065657), received between Sep 1, 2016 and Jul 17, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2017Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; THE CUSTOMER REPORTED AN ISSUE WITH A 40MM PLATE. DURING THE CASE, THE IMPLANT WAS PLACED READY TO BE FIXED. AT THIS POINT, THE SURGEON, COMMENTED THAT THE DEVICE WAS NOT COMPRESSING PROPERLY TO FIX TO THE SPINOUS PROCESSES WHEN HE WAS ROTATING THE INSTRUMENT THAT IS USED TO DO SO. THE CASE WAS COMPLETED USING ANOTHER OF THE SAME IMPLANT. THERE WERE A COUPLE OF MINUTES SURGICAL DELAY ONLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6719993 ↗
• MalfunctionSep 1, 2016Mechanical Problem; Failure to Align; Mechanical Problem

  IT WAS REPORTED THAT; CENTER LOCKING NUT WAS OFF TRACK, WOULD NOT LOCK ONTO PATIENTS SPINOUS PROCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5920691 ↗
• MalfunctionSep 1, 2016Mechanical Problem; Failure to Align; Mechanical Problem

  IT WAS REPORTED THAT; CENTER LOCKING NUT WAS OFF TRACK, WOULD NOT LOCK ONTO PATIENTS SPINOUS PROCESS.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 5920690 ↗