iFuse Implant System 7045M-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851085007480), received between Dec 17, 2020 and Dec 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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.

• InjuryDec 17, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE POST-OP CT SCANS REVELED THAT THE MIDDLE IMPLANT HAD SLIGHTLY BREACHED THE S1 NEUROFORAMEN; HOWEVER, THE PATIENT REPORTED NO PAIN SYMPTOMS, SO THE SURGEON DECIDED TO LEAVE THE IMPLANT IN PLACE. THE PATIENT HAD SI JOINT PAIN RELIEF FOR SEVERAL MONTHS BEFORE REPORTING TO A NEW SURGEON WITH COMPLAINTS OF LEFT SIDE RADICULAR PAIN FOLLOWING A FALL. IN (B)(6) 2020, THE SURGEON PERFORMED A DECOMPRESSION OF THE S1 NERVE ROOT. HE THEN USED A BURR TO REMOVE THE INFILTRATING BONE AND PART OF THE DISTAL TIP OF THE MIDDLE IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11032804 ↗