N/A 09-0313Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00841036028657), received between Mar 7, 2019 and Dec 16, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 17 most recent of 17 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 23819251 ↗
• 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 23819241 ↗
• 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 23819239 ↗
• 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 23819233 ↗
• 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 23819227 ↗
• 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 23819224 ↗
• 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 23819218 ↗
• 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 23819212 ↗
• MalfunctionAug 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT FRACTURED. NO KNOWN ADVERSE EVENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10443078 ↗
• MalfunctionAug 8, 2020Fracture; Fracture

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

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10383018 ↗
• MalfunctionApr 10, 2020Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9949796 ↗
• MalfunctionApr 10, 2020Fracture; Fracture

  NEW INFORMATION WAS RECEIVED THAT THIS EVENT IS A DUPLICATE TO A PREVIOUSLY REPORTED COMPLAINT. COMPLAINT IS A DUPLICATE TO (B)(4) AND REPORTED IN MEDWATCH 0001032347-2020-00082.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9949783 ↗
• MalfunctionFeb 3, 2020Fracture; Fracture

  IT WAS REPORTED AN ELEVATOR FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9661921 ↗
• MalfunctionDec 5, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9420691 ↗
• MalfunctionSep 12, 2019Fracture; Fracture

  IT WAS REPORTED THAT AN INSTRUMENT FRACTURED AND IT IS UNKNOWN IF THE INSTRUMENT FRACTURE OCCURRED DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9015779 ↗
• MalfunctionMay 10, 2019Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 8598843 ↗
• MalfunctionMar 7, 2019Fracture; Fracture

  IT WAS REPORTED THE ELEVATOR BROKE. AN X-RAY WAS PERFORMED TO ENSURE REMOVAL OF THE BROKEN PIECE; THERE WAS A DELAY OF 16-30 MINUTES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400094 ↗