MOSS 275010050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034194042), received between Oct 24, 2023 and Oct 8, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THERE WAS BREAKDOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20400618 ↗
• MalfunctionOct 25, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE BROKE AND BENT DURING A CASE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE MOSS MIAMI MAGNUM SPINE SYSTEM PEDICLE AWL 6.35CLOSE . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004536 ↗
• MalfunctionOct 24, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE AWL BROKE AND BENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A PEDICLE AWL. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997025 ↗