NA 4831-40-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295515791), received between Mar 22, 2023 and Dec 27, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEAD TRIALS HAD BECOME WORN OUT AND SCRATCHED OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398412 ↗
• MalfunctionMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES BETWEEN HEAD AND NECKS OF EMPHASYS WERE TOO TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635730 ↗
• MalfunctionMar 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON HAD STATED HEAD AND NECK TOLERANCES ARE TOO TIGHT WITH EMPHASYS. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16611654 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES ON ALL EMPHASIS TRIAL NECKS AND HEADS ARE TOO TIGHT. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594724 ↗