NA 499.223Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034792927), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjuryJan 7, 2021Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT USS DUAL OPENING HARDWARE REMOVAL SURGERY DUE TO BROKEN HARDWARE. THE SURGEON REMOVED THE POSTERIOR USS DUAL OPENING HARDWARE THAT WAS IMPLANTED IN THE YEAR 2012 DUE TO A THORACOLUMBAR SPINE FRACTURE. THERE WERE TWO (2) ISSUES WITH THE HARDWARE FROM THE 2012 SURGERY. THE LEFT ROD WAS BROKEN JUST CRANIAL TO THE L2 SCREW. ALSO, THE RIGHT L2 SCREW WAS BROKEN JUST BELOW THE HEAD OF THE SCREW. IT IS UNKNOWN WHEN THE HARDWARE BROKE. THERE WERE NO SCREWS PLACED AT L1 THE LEVEL OF THE FRACTURE. ALL THE HARDWARE WAS EASILY REMOVED, BUT THE TIP OF THE BROKEN SCREW REMAINS IN THE RIGHT L2 PEDICLE. THE SURGEON DECIDED THAT THERE IS NO PROBLEM LEAVING THIS BROKEN SCREW IN THE PATIENT AND THAT THERE WAS A RISK OF HARM TO THE PATIENT BY TRYING TO REMOVE THE BROKEN SCREW. THE PATIENT HAS SUCCESSFULLY HEALED AND THE REMOVAL WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: LOCKING/SET SCREWS: USS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 6.0MM TI HARD ROD 100MM (PART NUMBER 498.104 , LOT 6784859, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 6.2MM TI DUAL-OPENING SCREW 45MM THRD LENGTH F/6.0MM RODS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 11132658 ↗