VariAx 656414SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327070873), received between Feb 18, 2020 and Jul 1, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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.

• InjuryJul 1, 2025Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THE FOLLOWING: "WHEN INSERTING THE SCREW INTO THE BONE, AT THE START OF TIGHTENING, THE SCREW (HEAD) SPONTANEOUSLY BROKE OFF. IT WAS REMOVED AND REPLACED. ACTIONS: SCREW REMOVED THEN REPLACED. FINANCIAL LOSS + INCREASED OPERATING TIME.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375913 ↗
• MalfunctionOct 23, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "TWISTED-OFF SCREW HEAD OF A VARIAX2 T8 SCREW IN VARIAXDR OP. SCREW SHAFT HAS REMAINED IN THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 17989893 ↗
• MalfunctionApr 14, 2022Break; Fracture; Break; Fracture

  CUSTOMER REPORTED THAT A 2.7 VARIAX2 BONE SCREW HEAD SHEARED OFF LEAVING THE SHAFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14116136 ↗
• MalfunctionOct 4, 2021Fracture; Fracture

  AS REPORTED: "WHEN INSERTING THE BONE SCREW INTO THE PROXIMAL HOLE, THE SCREW BROKE AT THE HEAD. THE OPERATION WAS COMPLETED BY INSERTING ANOTHER SCREW WHILE THE SCREW TIP REMAINED IN THE BODY." THE TIP OF SCREW REMAINS IN PATIENT. NO ADVERSE IMPACT TO THE PATIENT REPORTED.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 12568383 ↗
• MalfunctionNov 17, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE 2.7 VARIAX CORTICAL SCREW BROKE AFTER BEING PUT THROUGH A PLATE DURING A DISTAL ORIF CASE. THE SURGEON HAD TO LEAVE THE BROKEN SCREW IN AS IT WOULD CAUSE MORE TROUBLE TAKING IT OUT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10855957 ↗
• MalfunctionJun 17, 2020Fracture; Fracture

  THE CUSTOMER REPORTED A BROKEN SCREW. SCREW HEAD STRIPPED OFF DURING PROCEDURE. THERE WAS A 20 MINUTE DELAY WHILE THE SCREW HEAD WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10165264 ↗
• MalfunctionFeb 18, 2020Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance

  THE SURGEON REPORTED THAT THE SCREW WAS INSERTED OK BUT ON TIGHTENING IT COULD NOT BE TIGHTENED A MUCH AS THE SURGEON WANTED, NEITHER COULD THE SCREW BE REMOVED. THE SURGEON NOTED DAMAGE TO THE END OF THE SCREW, WHICH IS LIKELY TO HAVE OCCURRED DURING TIGHTENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9721935 ↗