N/A 09-0262Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00841036028237), received between Jun 26, 2019 and Dec 16, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 15 most recent of 15 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 23819214 ↗
• 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 23819213 ↗
• 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 23819211 ↗
• 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 23819208 ↗
• 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 23819206 ↗
• 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 23819191 ↗
• MalfunctionJan 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ELEVATOR WAS DAMAGED BUT WAS LATER DISCOVERED TO BE FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229765 ↗
• MalfunctionJan 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ELEVATOR WAS DAMAGED BUT WAS LATER DISCOVERED TO BE FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229762 ↗
• MalfunctionJan 15, 2025Fracture; Fracture

  IT IS REPORTED THAT THE ELEVATOR FRACTURED DURING A PROCEDURE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158921 ↗
• MalfunctionJan 14, 2025Fracture; Fracture

  IT IS REPORTED THAT THE ELEVATOR FRACTURED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21155026 ↗
• MalfunctionSep 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT FRACTURED DURING A PROCEDURE. THE PIECE WAS RECOVERED WITH A DELAY BETWEEN FIVE AND TEN MINUTES. 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 15486652 ↗
• MalfunctionAug 3, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12269364 ↗
• MalfunctionOct 31, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260380 ↗
• MalfunctionJun 26, 2019Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE DOCTOR WAS LUXATING A TOOTH, THE TIP OF THE INSTRUMENT FRACTURED. THE TIP WAS EASILY SUCTIONED OUT. NO ADVERSE EVENTS HAVE BEEN REPORTS AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735616 ↗
• MalfunctionJun 26, 2019Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE DOCTOR WAS LUXATING A TOOTH, THE TIP OF THE INSTRUMENT FRACTURED. THE TIP WAS EASILY SUCTIONED OUT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735614 ↗