iFuse Implant System 7030-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00859256003262), received between Jun 24, 2016 and Jan 13, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Malposition of Device” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT HAD THE RIGHT SIDE OF A STAGED BILATERAL SI JOINT ARTHRODESIS PERFORMED IN (B)(6) 2019 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO THE SURGEON FOR A REVISION PROCEDURE. IT IS NOT KNOWN IF THE PATIENT HAD PAIN COMPLAINTS. THE SURGEON DID NOT DISCLOSE THE REASON FOR THE REVISION. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE INFERIOR POSITIONED IMPLANT AND REPLACED IT WITH DIFFERENT HARDWARE. THE PREEXISTING RIGHT SIDE SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11165086 ↗
• InjuryDec 1, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2013 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED RADICULAR PAIN SYMPTOMS YEARS LATER. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON REMOVED THE INFERIOR POSITIONED IMPLANT TO RELIEVE THE NERVE IMPINGEMENT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED, AND NO NEW HARDWARE WAS ADDED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10929145 ↗
• InjuryDec 2, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT HAD EXCELLENT SI JOINT PAIN RELIEF BEFORE COMPLAINING OF RIGHT HIP PAIN AFTER WEIGHT LOSS. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM CAUSING PAIN IN THE SURROUNDING TISSUE. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND INSTALLED A LARGER IMPLANT OF THE SAME TYPE IN THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS IMPROVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 9395980 ↗
• InjuryApr 10, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF CONTINUED SI JOINT PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CAUDAL POSITIONED IMPLANT WAS NOT SOLIDLY FIXED IN THE SACRUM BECAUSE IT WAS IN A BONE VOID. THE BONE VOID WAS NOT APPARENT DURING INTRAOPERATIVE IMAGING. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE OR MALPOSITIONED. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST CAUDAL IMPLANT USING CHISELS. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8499568 ↗
• InjuryApr 9, 2019Inadequacy of Device Shape and/or Size; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MOST CAUDAL POSITIONED IMPLANT WAS TOO SHORT AND NOT FULLY ACROSS THE SI JOINT. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST CAUDAL IMPLANT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8495561 ↗
• InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD STAGED BILATERAL SI JOINT ARTHRODESIS WITH THE RIGHT SIDE BEING PERFORMED IN (B)(6) 2016. THE PATIENT HAD OVER SIX MONTHS OF SI JOINT PAIN RELIEF BEFORE COMPLAINING OF A RECURRENCE OF RIGHT SIDE SI JOINT PAIN. THE SURGEON THOUGHT THAT THE MOST INFERIOR IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE INFERIOR IMPLANT AND REPLACED IT WITH A LARGER DIAMETER IMPLANT OF THE SAME TYPE USING THE SAME EXPLANT HOLE. HE THEN ADDED AN ADDITIONAL IMPLANT IN A MORE ANTERIOR POSITION TO THE EXISTING IMPLANTS TO HELP FIXATE THE SI JOINT. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE AND HER PAIN IS "UNDER CONTROL."

  Patient problems: Arthralgia; Pain

  MAUDE report 6527230 ↗
• InjuryJun 24, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF LEG NUMBNESS IN THE ABSENCE OF PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED VIA CT SCAN THAT THE PATIENT HAD ABNORMAL PELVIS ANATOMY AND THAT THE MOST CAUDAL IMPLANT WAS MALPOSITIONED. A FEW DAYS FOLLOWING THE INITIAL SURGERY, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CAUDAL IMPLANT AND PLACED AN IFUSE IMPLANT IN A MORE ANTERIOR POSITION BETWEEN THE FIRST AND SECOND IMPLANTS. THE PATIENT'S NUMBNESS RESOLVED AND HIS SI JOINT PAIN SYMPTOMS IMPROVED FOLLOWING THE REVISION SURGERY.

  Patient problems: Arthralgia; Nerve Proximity Nos (Not Otherwise Specified); Numbness; Undesired Nerve Stimulation

  MAUDE report 5749086 ↗