iFuse Implant System 7035-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00859256003279), received between Oct 22, 2015 and Oct 21, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Malposition of Device” (9 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. How this data works · Data updated Oct 13, 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.

• InjuryOct 21, 2021Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF CONTINUED SLIGHT SI JOINT PAIN. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IFUSE IMPLANT WAS TOO SHORT AND NOT FULLY ACROSS THE SI JOINT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT AND REPLACED IT WITH A LONGER IMPLANT OF THE SAME TYPE USING 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 12677800 ↗
• InjuryMar 20, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD A PERIOD OF SI JOINT PAIN RELIEF BEFORE REPORTING TO A DIFFERENT SURGEON WITH COMPLAINTS OF A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT MAY HAVE BEEN LOOSE BASED ON PERCEIVED LUCENCY ON CT IMAGES. 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 THE ILIUM. 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 8438821 ↗
• InjuryJul 12, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF CONTINUED RIGHT SI JOINT PAIN. THE SURGEON DETERMINED THAT THE MOST CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED AND LIKELY DID NOT CROSS THE SI JOINT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT AND REPLACED IT WITH A NEW LARGER IFUSE IMPLANT IN THE EXPLANT VOID AND ADDED AN ADDITIONAL IFUSE IMPLANT IN A MORE CAUDAL POSITION TO HELP FIXATE THE SI JOINT. THE SURGEON SAID THAT THE PATIENT'S PAIN HAS IMPROVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 7681706 ↗
• InjuryMar 1, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF CONTINUED SI JOINT PAIN. THE SURGEON DETERMINED THAT THE MOST CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED AND SHOWED LUCENCY. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT AND PLACED A LONGER IFUSE IMPLANT IN A MORE VENTRAL POSITION. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 7306790 ↗
• InjuryMar 1, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD AN EIGHT-MONTH PERIOD OF PAIN RELIEF BEFORE LATER REPORTING TO A NEW SURGEON WITH A RECURRENCE OF PAIN COMPLAINTS. THE SURGEON DETERMINED THAT THE MOST CAUDAL POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM CAUSING PAIN AROUND THE PROXIMAL END OF THE IMPLANT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Pain

  MAUDE report 7306735 ↗
• InjuryOct 17, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2011 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER PRESENTED TO A NEW SURGEON WITH PAIN COMPLAINTS. THE SURGEON DETERMINED THAT THE MOST CAUDAL IMPLANT WAS TOO PROUD OF THE ILIUM AND WAS IRRITATING THE SURROUNDING TISSUE. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT.

  Patient problems: Pain

  MAUDE report 6955285 ↗
• InjuryAug 25, 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 PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED VIA CT SCAN THAT THE CAUDAL IMPLANT HAD BREACHED THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE THE CAUDAL IMPLANT WAS BACKED OUT A FEW MILLIMETERS TO ALLEVIATE THE NERVE IMPINGEMENT. NO IMPLANTS WERE REMOVED. 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 5903612 ↗
• InjuryJul 20, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD NON-RADICULAR PAIN AROUND THE SURGICAL AREA FOLLOWING THE INITIAL SURGERY. A CT SCAN SHOWED THAT THE MOST CAUDAL IMPLANT WAS MALPOSITIONED BEING PLACED TOO POSTERIORLY AND LIKELY WASN'T FULLY CROSSING THE SI JOINT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST CAUDAL IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Arthralgia; Joint Disorder; Pain

  MAUDE report 5808608 ↗
• InjuryFeb 1, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. A FOLLOW-UP CT SCAN THE FOLLOWING DAY REVEALED THAN AN IMPLANT HAD NOT FULLY CROSSED THE SI JOINT INTO THE SACRUM. THE PATIENT DID NOT HAVE ANY PAIN COMPLAINTS. THE SURGEON PERFORMED A REVISION SURGERY A FEW DAYS LATER WHERE HE ADVANCED THE SECOND IMPLANT FURTHER ACROSS THE SI JOINT INTO THE SACRUM FOR A BETTER LONG TERM OUTCOME. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Joint Disorder

  MAUDE report 5401718 ↗
• InjuryOct 22, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IFUSE IMPLANTS WERE PLACED. THE PATIENT HAD LEG PAIN FOLLOWING THE PROCEDURE THAT DID NOT GO AWAY. THE SURGEON PERFORMED A CT SCAN THAT SHOWED THAT THE CAUDAL IMPLANT MAY HAVE BEEN IMPINGING ON THE NERVE ROOT. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CAUDAL IMPLANT. THE SURGERY WAS COMPLETED WITHOUT ANY INCIDENT. THE STATUS OF THE PATIENT FOLLOWING THE SURGERY IS NOT YET KNOWN.

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

  MAUDE report 5169762 ↗