VariAx 56-01210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540652461), received between Oct 24, 2017 and Nov 16, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2021Fracture; Fracture

  AS REPORTED: "WHEN USING VARIAX DR WITH AIMING BLOCK, THE SURGEON EXPERIENCED THAT THE NARROW BLOCK COULD NOT FIT/STICK TO THE PLATE. THE AIMING BLOCKS DOES MANAGE TO SIT TIGHT BUT ONLY THE NARROW ARE NOT ABLE TO. ALSO ONE OF THE FIXATION PINS ARE BROKEN." THE PROCEDURE WAS DELAYED BY A FEW MINUTES, THEY CHOSE TO USE THE DRILL GUIDE INSTEAD. NO DEBRIS WAS LEFT IN PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818712 ↗
• MalfunctionJan 26, 2021Fracture; Difficult to Remove; Fracture; Difficult to Remove

  AS REPORTED: "ONE FIXATION PIN FELT STUCK WHILE TRYING TO REMOVE IT FROM THE PLATE. WHEN IT CAME OUT, IT WAS BROKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231269 ↗
• MalfunctionDec 6, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON COULD NOT ATTACHED THE AIMING BLOCK TO THE VARIAXDR SMALL PLATE, AND FORCIBLY ATTACHED. THE SURGEON COULD NOT GET OUT OF THE BLOCK EASILY AFTER THE SCREWS WERE DEPLOYED, AND WHEN HE PULLED IT FORCIBLY, HE BROKE THE FIXATION PIN AND THE TIP OF THE PIN WAS LEFT IN THE PATIENT BODY. AFTER THAT, THE BROKEN PIECE WAS REMOVED WITH A FORCEPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139808 ↗
• MalfunctionJul 30, 2018Improper or Incorrect Procedure or Method; Component Missing

  THE AIMING BLOCK DID NOT ATTACH TO THE PLATE DURING THE OPERATION OF (B)(6) NOT USE THE BLOCK GUIDE AND USE TO THE POLYACCIAL GUIDE. CONFIRMED THE POSTOPERATIVE INSTRUMENTS, FOUND OUT THAT THERE WAS NO TIP OF THE AIMING BLOCK'S FIXATION PINS OUT OF THE THREE. IT IS UNKNOWN WHERE I LOST IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732918 ↗
• MalfunctionOct 24, 2017Break; Detachment Of Device Component

  I COULD NOT DISCONNECT THE AIMING BLOCK FROM THE PIN BECAUSE PART OF THE PIN IS GONE. COULD NOT FIND THE BROKEN PIECE OF THE PIN. IT MAY BE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6973045 ↗