iFuse Implant System 7065-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00859256003330), received between Aug 31, 2015 and Nov 23, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Malposition of Device” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. LATER THE PATIENT COMPLAINED OF RADICULAR PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR-POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISLES. THE IMPLANT WAS REPLACED WITH A SHORTER IMPLANT OF THE SAME TYPE IN A MORE POSTERIOR POSITION. 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 12862255 ↗
• InjuryNov 18, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD LEFT SIDE SI JOINT PAIN RELIEF FOR SEVERAL MONTHS BEFORE COMPLAINING OF A RECURRENCE OF PAIN SYMPTOMS AND REQUESTING THAT AN IMPLANT BE REMOVED. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN A BIT TOO PROUD OF THE ILIUM, BUT THAT IT WAS NOT LOOSE OR MOVING. IN (B)(6) 2020, THE SURGEON REMOVED THE SUPERIOR POSITIONED IMPLANT AND THEN INSTALLED A NEW, SHORTER, IMPLANT OF THE SAME TYPE IN A MORE ANTERIOR POSITION. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 10864894 ↗
• InjuryJul 20, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH CONTINUED RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT USING CHISELS. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. 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 10295703 ↗
• InjuryJan 23, 2018Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD INITIAL PAIN RELIEF FOLLOWING THE PROCEDURE BUT LATER COMPLAINED OF A RECURRENCE OF PAIN. THE SURGEON DETERMINED LUCENCY AROUND THE MOST SUPERIOR POSITIONED IMPLANT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED MOST SUPERIOR POSITIONED IMPLANT USING CHISELS AND REPLACED IT WITH A LARGER IFUSE IMPLANT. HE THEN ADDED AN ADDITIONAL IFUSE IMPLANT TO THE SI JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 7213526 ↗
• InjuryAug 31, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS AROUND 2015 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT PRESENTED TO A NEW SURGEON WITH COMPLAINTS OF RADICULAR AND LATERAL SOFT TISSUE PAIN CAUSED BY AN IMPLANT THAT WAS TOO LONG. IN (B)(6) 2017, THE SURGEON REMOVED THE IMPLANT. THE REMAINING PREVIOUS IMPLANTS WERE NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT KNOWN.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 6834109 ↗
• InjuryMay 26, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF LEFT LEG PAIN AFTER THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR IMPLANT WAS PLACED TOO DEEP AND HAD BREACHED THE NEUROFORAMEN. LATER THAT SAME DAY, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT AND REPLACED IT WITH A SHORTER ONE AND BACKED OUT THE OTHER IMPLANTS ABOUT A MILLIMETER EACH. THE PATIENT WAS DOING WELL THE FOLLOWING DAY.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 6595734 ↗
• InjurySep 8, 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 REPORTED RADICULAR PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED VIA CT SCAN THAT THE MOST CRANIAL IMPLANT WAS ENCROACHING ON THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. ONE WEEK AFTER THE INITIAL SURGERY, THE SURGEON PERFORMED A REVISION SURGERY WHERE THE CRANIAL IMPLANT WAS REMOVED AND REPLACED WITH A SHORTER IMPLANT. THE PATIENT'S RADICULAR PAIN SYMPTOMS IMPROVED FOLLOWING THE REVISION SURGERY.

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

  MAUDE report 5936060 ↗
• InjuryMar 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2014, THE PATIENT UNDERWENT LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT DID WELL FOR 18 MONTHS FOLLOWING THE INITIAL SURGERY BEFORE THE PAIN SYMPTOMS RETURNED. THE SURGEON THOUGHT THAT THE SUPERIOR IFUSE IMPLANT MAY HAVE BEEN LOOSE VIA CT SCAN. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT AND ADDED ADDITIONAL HARDWARE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Arthralgia; Joint Disorder

  MAUDE report 5527556 ↗
• InjuryNov 23, 2015Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS WITH THE RIGHT SIDE BEING PERFORMED IN (B)(6) 2015 AND THE LEFT IN (B)(6) 2015. THIS REPORT ONLY CONCERNS THE LEFT SI JOINT. THE PATIENT HAS NOT REPORTED ANY RIGHT SIDE SI JOINT COMPLAINTS.THE SURGEON INITIALLY THOUGHT THAT THE SUPERIOR IMPLANT MAY HAVE BREACHED THE SUPERIOR SURFACE OF THE ALA, BUT IT ACTUALLY APPEARED NOT TO HAVE DONE SO. HE ALSO USED NEUROMONITORING WITH NO POSITIVE RESULTS. THE PATIENT ALSO HAD CEMENT FROM A PREVIOUS FRACTURE SITE AND THERE WAS THE POSSIBILITY THAT THE IMPLANT MAY HAVE PUSHED THE CEMENT TOWARDS THE NEUROFORAMEN WHERE IT MAY HAVE IMPINGED ON THE NERVE, BUT THAT WAS NOT CONFIRMED.IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY ON THE LEFT SI JOINT WHERE HE REMOVED THE SUPERIOR IMPLANT AND FILLED THE HOLE WITH BONE GRAFT. HE THEN ADDED A NEW SHORTER IMPLANT INFERIOR TO THE PRE-EXISTING SECOND IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

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

  MAUDE report 5244689 ↗
• InjuryAug 31, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF LEG PAIN THE FOLLOWING DAY AFTER WALKING. A CT SCAN REVEALED THAT THE SUPERIOR IMPLANT WAS CLOSE TO THE L5 NERVE. THREE DAYS AFTER THE INITIAL SURGERY, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT. THE PATIENT'S PAIN SYMPTOMS IMPROVED FOLLOWING THE REVISION.

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

  MAUDE report 5042791 ↗