Jet-X 71067382Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010607928), received between Feb 15, 2021 and Jul 2, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2021Break; Break

  IT WAS REPORTED THAT ONE (1) FREEDOM POST IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112054 ↗
• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT THE NUT OF THE FREEDOM POST BROKE WHILE TIGHTENING. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO INJURY TO THE PATIENT WAS 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 11326813 ↗
• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT THE NUT OF THE FREEDOM POST BROKE WHILE TIGHTENING. EVENT OCCURRED DURING USE. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS 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 11326812 ↗