VariAx 656418SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327070897), received between Dec 19, 2019 and Aug 31, 2022 — classified as 2 malfunctions.

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

• MalfunctionAug 31, 2022Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THE HEAD SHEARED OFF THE SCREW AND THE THREADS WERE LEFT IN SITU IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY. DELAY OF 5 MINS WHILST TRYING TO RETRIEVE BROKEN PART OF SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 15326395 ↗
• 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 9492906 ↗