ILIZAROV SYSTEMS 103101Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08033201842065), received between Aug 19, 2020 and Apr 7, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2021Unstable; Unstable

  IT WAS REPORTED THAT, WHEN CHECKING A DYNAMOMETRIC WIRE TENSIONER BEFORE CASE IN CENTRAL STERILE PROCESSING, IT WAS NO LONGER HOLDING TENSION. AS INCIDENT OCCURRED BEFORE THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627299 ↗
• MalfunctionMar 1, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY THE DYNAMOMETRIC WIRE TENSIONER FAILED TO TIGHTEN. SURGERY BEING DONE WAS A DEFORMITY. INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391108 ↗
• MalfunctionNov 3, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TENSIONERS ARE NOT WORKING PROPERLY. NO PATIENT INVOLVED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10779914 ↗
• MalfunctionNov 3, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TENSIONERS ARE NOT WORKING PROPERLY. NO PATIENT INVOLVED IN THE CASE.

  Patient problems: No Patient Involvement

  MAUDE report 10779474 ↗
• MalfunctionAug 26, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE DYNAMOMETRIC WIRE TENSIONER NO LONGER TENSIONS. IT WAS FOUND DURING SET UP/INSPECTION. NO DELAY. S&N BACK UP WAS AVAILABLE TO COMPLETE THE TREATMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10457282 ↗
• MalfunctionAug 19, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT BEFORE THE PROCEDURE WHEN IT PRE-BUILDING THE FRAME THAT THE TENSIONER DID NOT TENSION PROPERLY.

  Patient problems: No Patient Involvement

  MAUDE report 10428768 ↗