iFuse Implant System 4040-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859256003415), received between May 22, 2019 and May 22, 2019 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS SOMETIME IN 2014 WHERE TWO IMPLANTS WERE INSTALLED. IN (B)(6) 2014, THE PATIENT HAD AN ADDITIONAL PROCEDURE WHERE TWO ADDITIONAL IMPLANTS OF THE SAME TYPE WERE ADDED TO THE RIGHT SI JOINT FOR ADDITIONAL FIXATION. THE SURGEON LATER DECIDED TO REMOVE ALL THE IMPLANTS. THE SURGEON DID NOT OFFER A REASON FOR THE REMOVAL AND DID NOT INDICATE THAT THE IMPLANTS WERE LOOSE OR MALPOSITIONED. IMAGING DID NOT APPEAR TO SHOW MALPOSITIONING OR LUCENCY. IN (B)(6) 2019, THE SURGEON REMOVED ALL THE IMPLANTS WITH CHISELS AS THEY WERE SOLIDLY FIX IN BONE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8634015 ↗