iFuse Implant System 7040-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00859256003286), received between Oct 2, 2015 and Mar 31, 2020 — classified as 19 injuries.

The most frequently reported specific device problem is “Malposition of Device” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD SI JOINT ARTHRODESIS IN (B)(6) 2014 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT HAD A PERIOD OF PAIN RELIEF BUT LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS MALPOSITIONED AND LOOSE. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND REPLACED IT WITH A LARGER IMPLANT OF THE SAME TYPE. AN ADDITIONAL IMPLANT WAS ALSO INSTALLED TO HELP FIXATE THE SI JOINT. THE PATIENT'S JOINT APPEARS TO BE BETTER STABILIZED WITH LESS PAIN.

  Patient problems: Arthralgia

  MAUDE report 9905463 ↗
• InjuryJan 7, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2013 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD GOOD SI JOINT PAIN RELIEF FOR MANY YEARS BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS MALPOSITIONED. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND REPLACED IT WITH DIFFERENT HARDWARE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 9558224 ↗
• InjuryOct 11, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF CONTINUING SI JOINT PAIN. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT WAS NOT FULLY ACROSS THE SI JOINT AND WAS ALSO TOO PROUD OF THE ILIUM. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2019, THE SURGEON ADVANCED THE MIDDLE IMPLANTS A FEW MILLIMETERS DEEPER ACROSS THE SI JOINT AND ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE TO HELP FIXATE THE JOINT. 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 9180399 ↗
• InjuryJul 19, 2019Inadequacy 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) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED, 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 REMOVED THE CAUDAL POSITIONED IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE. 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 8809474 ↗
• InjuryJul 3, 2019Inadequacy 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) 2016 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF CONTINUING SI JOINT PAIN. 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 REMOVED THE IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND REPLACED IT WITH A LONGER IMPLANT OF THE SAME TYPE AND ADDED ADDITIONAL HARDWARE. 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 8760447 ↗
• InjuryMar 27, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED ON EACH SIDE. THE PATIENT HAD SEVERAL LUMBAR FUSIONS AFTER THE INITIAL SI JOINT ARTHRODESIS. THE PATIENT HAD A LONG PERIOD OF SI JOINT PAIN RELIEF BEFORE COMPLAINING OF NEW RADICULAR PAIN AFTER A FALL. THE SURGEON DETERMINED THAT THE RIGHT SIDE SUPERIOR IMPLANT MAY HAVE BEEN IMPINGING ON THE NERVE ROOT. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE SUPERIOR POSITIONED IMPLANT WITH CHISELS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Fall; Undesired Nerve Stimulation

  MAUDE report 8458374 ↗
• InjuryMar 8, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD OVER SIX MONTHS OF SI JOINT PAIN RELIEF BEFORE COMPLAINING OF A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE IMPLANTS 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 AND REPLACED IT WITH AN IMPLANT OF THE SAME TYPE. HE THEN PLACED TWO ADDITIONAL IMPLANTS OF THE SAME TYPE TO HELP FIXATE THE SI JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 8405451 ↗
• InjuryJan 25, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED CONTINUED PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON ATTEMPTED TO REMOVE THE MIDDLE IMPLANT, BUT IT WAS SOLIDLY FIXED IN BONE AND HE COULD NOT REMOVE IT. HE LEFT THE IMPLANT IN PLACE AND INJECTED THE LEFT SI JOINT WITH ANESTHETIC FOR IMMEDIATE PAIN RELIEF. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8278099 ↗
• InjuryDec 20, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT DID WELL INITIALLY FOLLOWING THE PROCEDURE BUT LATER COMPLAINED OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT AND REPLACED IT WITH A WIDER IMPLANT OF THE SAME TYPE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE MALPOSITIONED. THE PATIENT IS DOING BETTER POST-OP.

  Patient problems: Arthralgia

  MAUDE report 8185649 ↗
• InjuryNov 1, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF LITTLE PAIN RELIEF. THE SURGEON THOUGHT THAT THE MIDDLE IMPLANT MAY HAVE BEEN TOO SHORT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MIDDLE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND REPLACED IT WITH A LARGER IMPLANT PF THE SAME TYPE. HE THEN ADDED AN ADDITIONAL IMPLANT, AGAIN OF THE SAME TYPE, AND BONE GRAFT TO THE JOINT TO HELP FIXATE THE JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8030786 ↗
• InjuryOct 25, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR ONE YEAR FOLLOWING THE INITIAL PROCEDURE BEFORE REPORTING NEW PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MOST INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED 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 8007086 ↗
• InjuryDec 5, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF PAIN AROUND THE SI JOINT. THE SURGEON DETERMINED THAT THE MOST CAUDAL IMPLANT WAS TOO PROUD OF THE ILIUM CAUSING PAIN AROUND THE PROXIMAL END OF THE IMPLANT. IN (B)(6) 2017, SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CAUDAL IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Pain

  MAUDE report 7082888 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD INITIAL PAIN RELIEF BUT LATER COMPLAINED OF RESIDUAL PAIN. THE SURGEON DETERMINED THAT THE SECOND IMPLANT MAY HAVE BEEN IMPINGING ON A NERVE. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE BACKED OUT THE SECOND IMPLANT APPROXIMATELY TWO MILLIMETERS TO ALLEVIATE THE NERVE IMPINGEMENT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6720119 ↗
• InjuryMay 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT DID WELL INITIALLY BUT LATER COMPLAINED OF A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT WAS NOT FULLY ACROSS THE SI JOINT. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MIDDLE IMPLANT AND REPLACED IT WITH A LONGER IMPLANT AND ADDED TWO ADDITIONAL IMPLANTS. THE PATIENT IS DOING BETTER FOLLOWING THE PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 6595524 ↗
• InjuryMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2014 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT DID WELL INITIALLY BUT LATER COMPLAINED OF A RECURRENCE OF LEFT SIDE SI JOINT PAIN. THE SURGEON THOUGHT THAT SOME OF THE IMPLANTS MAY HAVE BEEN LOOSE. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE FIRST TRIED TO REMOVE THE MIDDLE IMPLANT BUT IT WAS SOLIDLY FIXED IN BONE AND COULD NOT BE MOVED. HE THEN REMOVED THE INFERIOR POSITIONED IMPLANT AND REPLACED IT WITH A WIDER IMPLANT OF THE SAME TYPE. FINALLY HE ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE ANTERIOR TO THE MIDDLE IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT YET KNOWN.

  Patient problems: Arthralgia; Pain

  MAUDE report 6540354 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN RELIEF FOR 18 MONTHS FOLLOWING INITIAL SI JOINT ARTHRODESIS IN (B)(6) 2013 BUT LATER COMPLAINED OF A RECURRENCE OF SI JOINT PAIN. THE SURGEON BELIEVED THAT THERE WAS LOOSENING OF TWO OF THE SI JOINT IMPLANTS BASED ON CT SCANS. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST CRANIAL IMPLANT. THE OTHER PREEXISTING IMPLANTS WERE LEFT IN PLACE. THE PATIENT "SEEMED TO DO WELL" FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia; Joint Disorder

  MAUDE report 6260836 ↗
• InjuryOct 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT INITIALLY HAD PAIN RELIEF FOLLOWING THE PROCEDURE BUT LATER HAD A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED VIA X-RAYS AND CT SCANS THAT THERE WAS LUCENCY AROUND THE MOST CAUDAL IMPLANT. THE PATIENT HAS OSTEOPOROSIS. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST CAUDAL IMPLANT AND FILLED THE EXPLANT HOLE WITH BONE GRAFT. HE THEN ADDED AN ADDITIONAL IMPLANT DORSAL TO THE MOST CEPHALAD PREEXISTING IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Arthralgia; Joint Disorder; Osteopenia/ Osteoporosis

  MAUDE report 6018979 ↗
• InjuryAug 25, 2016Malposition of Device; Malposition of Device

  THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2011 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR PAIN AFTER THE INITIAL SURGERY. THE PATIENT LATER PRESENTED TO A DIFFERENT SURGEON THAT DETERMINED THAT THE SUPERIOR IMPLANT WAS MALPOSITIONED AND HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT YET KNOWN.

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

  MAUDE report 5903608 ↗
• InjuryOct 2, 2015Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT SIDE IFUSE SI JOINT ARTHRODESIS WHERE THREE IFUSE IMPLANTS WERE PLACED. ALL IMPLANTS APPEARED TO BE IN BONE AND WELL ACROSS THE JOINT FOLLOWING THE INITIAL SURGERY. THE PATIENT LATER HAD PAIN COMPLAINTS. THE PATIENT CONTACTED A NEW SURGEON WHO PERFORMED A REVISION SURGERY IN (B)(6) 2015 WHERE HE REMOVED THE SHORTEST OF THE INITIAL IFUSE IMPLANTS AND REPLACED IT WITH A FIVE MILLIMETER LONGER IFUSE IMPLANT USING THE SAME EXPLANT HOLE. THE INITIAL IMPLANT WAS VERY DIFFICULT TO REMOVE AS IT WAS SOLIDLY IN BONE AND REQUIRED APPROXIMATELY 30 TO 40 STRIKES WITH THE MALLET TO BACK THE IMPLANT OUT USING THE REMOVAL TOOL. THE SURGEON ALSO PERFORMED A PIRIFORMIS RELEASE IMMEDIATELY FOLLOWING THE SI JOINT REVISION SURGERY. THE STATUS OF THE PATIENT FOLLOWING THE SURGERY IS NOT YET KNOWN.

  Patient problems: Arthralgia

  MAUDE report 5123776 ↗