iFuse Implant System 7035M-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00851085007466), received between Mar 1, 2021 and Dec 6, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2021Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE TWO IMPLANTS WERE INSTALLED TO AUGMENT A DIFFERENT SCREW IN THE JOINT. ON (B)(6) 2021, THE SURGEON REMOVED THE SCREW AND AN ADDITIONAL IMPLANT OF THE SAME TYPE AS THOSE INSTALLED ON (B)(6) 2019. THE SURGEON DETERMINED THAT THE INITIAL CAUDAL POSITIONED IMPLANT WAS TOO SHORT AND INEFFECTIVE. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SHORT IMPLANT AND REPLACED IT WITH A LARGER IMPLANT OF THE SAME TYPE. 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 12937443 ↗
• InjuryNov 11, 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) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR APPROXIMATELY SIX MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DID NOT DETERMINE THAT ANY OF THE IMPLANTS WERE LOOSE OR MALPOSITIONED BUT DECIDED TO REMOVE CAUSAL POSITIONED IMPLANT REGARDLESS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT. 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 12800516 ↗
• InjuryMar 1, 2021Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Inadequacy of Device Shape and/or Size; Loss of Osseointegration

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. SIDE. THE PATIENT HAD SI JOINT PAIN RELIEF FOR APPROXIMATELY SIX MONTHS AFTER THE INITIAL PROCEDURE BEFORE COMPLAINING ABOUT A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED LOOSENING OF THE CAUDAL POSITIONED IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A LONGER AND WIDER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 11395345 ↗