VariAx 656416SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327070880), received between Jul 24, 2019 and Dec 19, 2019 — classified as 2 malfunctions.

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

• MalfunctionDec 19, 2019Fracture; Fracture

  THE STRYKER SALES REP REPORTED THAT THE HEADS OF TWO VARIAX BONE SCREWS HAVE COME OFF, RESULTING IN THE SCREW SHAFTS STAYING IN THE PATIENT. ADDITIONALLY: THE HEADS DID NOT FALL INTO THE PATIENT. THE SURGEON WAS NOT WORKING AT AN EXTREME ANGLE. RE BONE QUALITY - THE PATIENT WAS RELATIVELY YOUNG MALE OF 30-40 YEARS.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9492822 ↗
• MalfunctionJul 24, 2019Break; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT THE SURGEON WAS PLACING THE SCREW IN ON HAND INTO A PATIENT, WHEN THE SCREW HEAD CAME AWAY FROM THE SCREW ITSELF AS HE MADE THE FINAL FEW TURNS. BONE QUALITY WAS GOOD. THE SCREW HEAD DID NOT FALL INTO THE PATIENT. FINAL TIGHTENING WAS MADE BY HAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8824840 ↗