NA 09.633.185Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034763224), received between Mar 11, 2022 and Mar 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMar 12, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE 5.5 PRECON ROD 80MM STR LEN/400MM AND 5.5MM TI HARD ROD 400MM WERE FOUND BROKE, DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.5 PRECON ROD 80MM STR LEN/400MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742742 ↗
• MalfunctionMar 11, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCOLIO ROD WAS DISCOVERED AS BROKEN DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCOLIO ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13733671 ↗