USS 03.607.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034712932), received between Jul 22, 2022 and Jul 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 29, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 , THE HANDLE WAS STICKING DURING USE. THE FAULT CAUSED NO HARM TO THE PATIENT AND CASE WENT AHEAD AS PLANNED WITH NO DELAY. THE INSTRUMENT WAS HARD TO USE AND REQUIRES REPLACING. THIS REPORT INVOLVES ONE (1) ROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128767 ↗
• MalfunctionJul 22, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THE POLY ROD INTRODUCER WAS PARTICULARLY STIFF AND NEEDS LUBRICATING PRIOR TO NEXT USAGE. THIS REPORT INVOLVES ONE (1) ROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087728 ↗