VariAx 53-27616SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540593979), received between May 10, 2019 and Sep 3, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2019Break; Difficult to Remove; Detachment of Device or Device Component

  THE PATIENT UNDERWENT AN OSTEOSYNTHESIS USING VADR ON (B)(6) 2019. DURING SURGERY, THE SCREW HEAD BROKE OFF WHEN THE SURGEON TIGHTEN THE SCREW TO THE SCREW HOLE OF THE SHAFT BONE. THE PATIENT BONE WAS HARD. THE SCREW SHAFT THAT LOSS OF THE HEAD COULD NOT BE REMOVED FROM THE PATIENT, IT WAS REMAINED AS IT IS.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8958261 ↗
• MalfunctionMay 10, 2019Break

  IT WAS REPORTED BY THE PHARMACY TO THE GENERAL MANAGER THAT ON (B)(6) 2019, DOCTOR REPORTED AN INCIDENT TO (B)(6) CONCERNING A STRYKER SCREW WITH THE FOLLOWING EVENT: "WHEN A SELF-TAPPING SCREW WAS SCREWED ONTO THE PLATE, THE HEAD BROKE AND THE SCREW BODY REMAINED IN A PLACE WITHOUT BEING ABLE TO REMOVE IT. I GOT THE SCREWS AND THE HEAD BACK. THERE WAS A LONGER INTERVENTION DUE DIFFICULTIES IN REMOVING THE BROKEN SCREW.

  Patient problems: No Information

  MAUDE report 8600940 ↗