iFuse Implant System 7040M-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851085007473), received between Sep 10, 2021 and Sep 10, 2021 — 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.

• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR APPROXIMATELY 18 MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON THOUGHT THE MIDDLE IMPLANT MAY HAVE BEEN LOOSE EVEN THOUGH NO LUCENCY WAS SEEN ON IMAGING. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND NOT LOOSE. THE IMPLANT HAD GOOD BONE IN/ON-GROWTH. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT, NOR WAS ANY ADDITIONAL HARDWARE ADDED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 12457231 ↗