MOSS 279712350Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034198880), received between Mar 20, 2020 and Feb 7, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE MMSI HEAD ADJUSTER (FROM THE EXPEDIUM DEFORMITIES SET) WAS FAULTY. IT WAS ALMOST IMPOSSIBLE TO REMOVE FROM ONE HANDLE AND IT WOULDN'T LOCK INTO THE OTHER HANDLES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337057 ↗
• MalfunctionJul 18, 2024Break; Break

  IT WAS REPORTED THAT ON JUNE 24, 2024, A SALES REP. WAS IN A BIG DEFORMITY CASE WITH THE DR. DURING THE CASE, TWO OF THE STRAIGHT DRIVERS WERE STRIPPED. IN ADDITION TO THIS, A HEAD TURNER ALSO BROKE WHILE ATTEMPTING TO ADJUST THE HEAD OF AN IMPLANT SCREW. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES. NO FRAGMENTS WERE GENERATED. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MMSI HEAD ADJUSTER. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773053 ↗
• MalfunctionMar 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE CASE, THE STRAIGHT DRIVER WAS STRIPPED AND HEAD TURNER WAS BENT. THERE WAS NO SURGERY DELAY AND NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) MMSI HEAD ADJUSTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912846 ↗
• MalfunctionDec 2, 2020Device Markings/Labelling Problem; Device-Device Incompatibility; Device Markings/Labelling Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING INSPECTION IT WAS NOTICED THAT THE TIP OF THE INSERTER FELL APART AND THE GOLDEN MARKING OF THE HEAD POSITIONER WAS NOT POSITIONED CORRECTLY. IT COULD NOT BE CONNECTED TO THE HANDLE. NO SURGICAL INVOLVEMENT. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) MOSS MIAMI SPINE SYSTEM POLYAXIAL HEAD POSITIONER 5.5. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936558 ↗
• MalfunctionMar 20, 2020Break; Break

  CONCOMITANT DEVICES REPORTED: TEAR-DROP HANDLE (PART# 279702120, LOT# 0807MI, QUANTITY# 1).

  Patient problems: No Patient Involvement

  MAUDE report 9861348 ↗