UniVise 48590035Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327065640), received between May 25, 2016 and May 25, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance” (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.

• MalfunctionMay 25, 2016Physical Resistance

  IT WAS REPORTED THAT; DR. WAS ATTEMPTING TO PUT THE PLATE ON, HE WAS TIGHTENING THE PLATE ONTO THE SPINOUS PROCESS WITH THE INSERTER INNER SHAFT, HOWEVER HE WAS MEETING RESISTANCE AFTER ONLY A FEW TURNS AND THE SPIKES HAD NOT EVEN ENGAGED THE SPINOUS PROCESS YET. THE DOCTOR PULLED THE INSERTER AND IMPLANT OUT, HE HAD THE TECH REATTACH THE PLATE TO THE INSERTER, AND TRIED AGAIN. DR MET TACTILE RESISTANCE AGAIN AFTER ONLY A FEW TURNS AND IMPLANT STILL WAS NOT ENGAGING. DR. REPEATED THE SAME STEPS WITH THE TECH READJUSTING THE IMPLANT, I WATCHED THE TECH LOAD THE IMPLANT ALL THREE TIMES, THE IMPLANT WAS ARROW TO ARROW, AND FLUSH WITH INSERTER. THE DR.'S 3RD ATTEMPT, THE SAME RESISTANCE WAS MET, WE ALSO SWITCHED TO A SECOND UNIVISE INSERTER AT THIS POINT. THE DOCTOR ASKED ME FOR A NEW IMPLANT, SO I GAVE HIM ONE. HE ATTEMPTED TO PUT THE NEW IMPLANT IN, SAME RESISTANCE WAS MET, DR. PULLED THE IMPLANT AND INSERTER OUT, LOOSENED UP THE INNERSHAFT ALL THE WAY, THEN STARTED TIGHTENING IT DOWN OUTSIDE THE BODY, AND IT WORKED FINE, LOOSENED INNER SHAFT AGAIN, PUT IMPLANT IN, WORKED JUST FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5680453 ↗