N/A 09-0394Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036029203), received between Dec 16, 2025 and Dec 16, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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. How this data works · Data updated Oct 13, 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 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ELEVATOR WAS DISCOVERED TO BE WORN OVER TIME AND NEEDED REPLACING. NO SPECIFIC SURGERY OR PATIENT WAS INVOLVED, AND NO PATIENT HARM WAS REPORTED. INVESTIGATION OF THE RETURNED DEVICE HAS CONCLUDED THAT THE INSTRUMENT HAS A FRACTURED TIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819268 ↗
• MalfunctionDec 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ELEVATOR WAS DISCOVERED TO BE WORN OVER TIME AND NEEDED REPLACING. NO SPECIFIC SURGERY OR PATIENT WAS INVOLVED, AND NO PATIENT HARM WAS REPORTED. INVESTIGATION OF THE RETURNED DEVICE HAS CONCLUDED THAT THE INSTRUMENT HAS A FRACTURED TIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819261 ↗
• MalfunctionDec 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ELEVATOR WAS DISCOVERED TO BE WORN OVER TIME AND NEEDED REPLACING. NO SPECIFIC SURGERY OR PATIENT WAS INVOLVED, AND NO PATIENT HARM WAS REPORTED. INVESTIGATION OF THE RETURNED DEVICE HAS CONCLUDED THAT THE INSTRUMENT HAS A FRACTURED TIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819260 ↗
• MalfunctionDec 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ELEVATOR WAS DISCOVERED TO BE WORN OVER TIME AND NEEDED REPLACING. NO SPECIFIC SURGERY OR PATIENT WAS INVOLVED, AND NO PATIENT HARM WAS REPORTED. INVESTIGATION OF THE RETURNED DEVICE HAS CONCLUDED THAT THE INSTRUMENT HAS A FRACTURED TIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819246 ↗