UNIVERSAL NEURO 3 56-15904Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 34546540684920), received between May 16, 2019 and Jun 4, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2019Device Slipped

  IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING A BRAIN TUMOR CASE, WHILE PREPARING TO CLOSE THE SKULL FLAP, THE SURGEON HAD DIFFICULTY PURCHASING THE BONE WITH THE SCREWS, AND THE SCREWS SLIPPED SEVERAL TIMES. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666335 ↗
• MalfunctionJun 4, 2019Device Slipped

  IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING A HYDROCEPHALUS PROCEDURE, THE SURGEON HAD DIFFICULTIES PURCHASING THE BONE WITH THE SCREW, AND THE SCREW SLIPPED. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666258 ↗
• InjuryJun 4, 2019Device Slipped

  IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING A BRAIN TUMOR OPERATION, THE SURGEON FOUND THAT THE SCREW HAD DIFFICULTY PURCHASING THE BONE. HE APPLIED MORE FORCE BUT THEN THE SCREW SLIPPED AND DAMAGED THE DURA MATER AND THE BRAIN.

  Patient problems: Brain Injury

  MAUDE report 8666255 ↗
• MalfunctionMay 22, 2019Device Slipped

  IT WAS REPORTED BY A DISTRIBUTOR THAT DURING A SURGICAL PROCEDURE IT WAS FOUND THAT SCREW SLIPPAGE WAS MAKING IT DIFFICULT TO PICK UP THE DESIGNATED SCREWS, AND ONCE PICKED UP THE SCREWS SLIPPED. THERE WAS NO MEDICAL INTERVENTION, AND THERE WERE NO ADVERSE CONSEQUENCES WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8632039 ↗
• MalfunctionMay 16, 2019Device Slipped

  IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING THE CLOSURE OF THE BONE FLAP, THE SCREW SLIPPED SEVERAL TIMES BEFORE SURGEON COULD COMPLETELY DRIVE IN THE SCREW IN. THERE WAS NO SIGNIFICANT DELAY OR PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617851 ↗
• MalfunctionMay 16, 2019Device Slipped

  IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS AN ISSUE DURING A HYDROCEPHALUS CASE. WHILE THE SURGEON WAS IMPLANTING A SCREW HE COULD NOT PROPERLY DRIVE SCREW INTO THE SKULL AS IT KEPT SLIPPING. THERE WAS NO SIGNIFICANT DELAY OR PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8617849 ↗
• MalfunctionMay 16, 2019Device Slipped

  IT WAS REPORTED BY DISTRIBUTOR THAT DURING THE CRANIOTOMY, THE SURGEON COULD NOT DRIVE SCREW INTO THE SKULL PROPERLY DUE TO SLIPPING OF SCREW. THERE WAS NO SIGNIFICANT DELAY OR PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8617848 ↗