NA 1116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734400145), received between Aug 11, 2020 and Dec 21, 2023 — classified as 3 injuries.

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.

• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT IS EXPERIENCING HEADACHES FROM A CEREBROSPINAL FLUID (CSF LEAK) FOLLOWING A PROCEDURE ON 29 NOVEMBER 2023. PATIENT WAS PRESCRIBED MEDICATION.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 18373418 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CEREBROSPINAL FLUID LEAK (CSF) OCCURRED WHILE THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE EPIDURAL SPACE. THE PROCEDURE WAS THEN ABORTED AND ALL INCISIONS WERE CLOSED. NO FURTHER INTERVENTION IS PENDING.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 15203797 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERM IMPLANT PROCEDURE ON (B)(6) 2020, THE PHYSICIAN PUNCTURED THE EPIDURAL SPACE DURING ENTRY RESULTING IN A CEREBROSPINAL FLUID (CSF) LEAK. THE PHYSICIAN COMPLETED THE PROCEDURE BY ENTERING AT A DIFFERENT LEVEL. POST-OPERATIVELY, THE PATIENT EXPERIENCED A HEADACHE WHICH RESOLVED OVER TIME WITH PRESCRIBED MEDICATION.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 10389189 ↗