NA 702462Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540112149), received between Mar 9, 2020 and Dec 16, 2025 — classified as 1 injury, 1 malfunction.

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

• InjuryDec 16, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED: "AN EXCESSIVELY LONG ASNIS SCREW WAS SELECTED, AND IT PIERCED THE HEAD OF THE COLLUM. THE PATIENT IS IN PAIN AND SAYS THAT THE SPECIALIST USED SCREWS THAT WERE TOO LONG. THE SPECIALIST SAYS THAT IT IS DUE TO THE STRYKER MEASURING INSTRUMENT. THE SCREW WAS REVISED ON (B)(6)."

  Patient problems: Pain; Perforation

  MAUDE report 23818251 ↗
• MalfunctionMar 9, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE SURGEON REPORTED THAT AS HE WAS USING THE MEASURING DEVICE WITH A GUIDE WIRE, THE DEVICE DID NOT APPEAR TO BE MEASURING CORRECTLY AND IT RESULTED IN THE SURGEON CHOOSING A SCREW THAT WAS TOO LONG. THE SCREW WAS REMOVED AND REPLACED WITH A SHORTER SCREW. THE SURGEON IS NOT SURE WHETHER THE MEASURING DEVICE, K-WIRE OR SCREW ARE AT ISSUE. THE KIT HAS BEEN IN USE AT THIS FACILITY FOR SOME YEARS WITHOUT ANY OTHER ISSUES BEING REPORTED FOR MEASURING FUNCTION. THERE WAS A DELAY, (LENGTH OF DELAY UNKNOWN) BUT THIS WAS LESS THAT 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9809075 ↗