VariAx 656116SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327070538), received between May 12, 2023 and May 12, 2023 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT HAD ORTHOPAEDIC SURGERY. STAFF COMMENTED POST SURGERY THAT SURGERY GUIDES WERE LOOSE. THEREFORE RADIOLOGICAL SCAN WAS PERFORMED AND AN EXAMINATION OF THE SCAN SHOWED THAT RETAINED OBJECT LOOKED TO BE A SCREW HEAD OF APROX 2.4MM DIAMETER. IDENTIFIED THAT SCREW WAS FROM THE STRYKER VARIAX2 BONE SCREW USED DURING OPERATION. SURGEON REOPENED OPERATION SITE, BUT COULD NOT LOCATE METAL PIECE. DECISION WAS MADE TO LEAVE IT AS EXPLORATORY SURGERY WOULD CAUSE MORE HARM."

  Patient problems: Foreign Body In Patient

  MAUDE report 16918265 ↗