iFuse Implant System 7045-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00859256003293), received between Oct 28, 2015 and Oct 21, 2021 — classified as 21 injuries.

The most frequently reported specific device problem is “Malposition of Device” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN IMMEDIATELY AFTER THE INITIAL SURGERY. SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING A BONE CHIP TO IRRITATE THE NERVE. THE PATIENT HAD MEDICAL ISSUES THAT REQUIRED POSTPONEMENT OF THE REVISION PROCEDURE FOR A YEAR. IN (B)(6) 2021, SURGEON PERFORMED A REVISION PROCEDURE WHERE THE SUPERIOR POSITIONED USING CHISELS. THE EXPLANT HOLE WAS NOT FILLED WITH BONE GRAFT. AN ILIOSACRAL SCREW WAS ADDED ABOVE THE EXPLANT VOID. NON 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 12677694 ↗
• InjuryNov 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH A RECURRENCE OF RIGHT SIDE SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED NON-UNION OF THE SI JOINT. THE SURGEON DID NOT INDICATE THAT THE IMPLANTS WERE LOOSE OR MALPOSITIONED. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A WIDER IMPLANT OF THE SAME TYPE IN THE EXPLANT VOID. HE THEN INSTALLED TWO ADDITIONAL IMPLANTS OF THE SAME TYPE INTO THE RIGHT SI JOINT. THE PREEXISTING INFERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT NOW HAS FOUR IMPLANTS IN HIS RIGHT SI JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 10854399 ↗
• InjuryOct 15, 2020Inadequacy 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) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH A RECURRENCE OF RIGHT SIDE SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED NON-UNION OF THE SI JOINT. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A WIDER IMPLANT OF THE SAME TYPE IN THE EXPLANT VOID. HE THEN INSTALLED TWO ADDITIONAL INTO THE RIGHT SI JOINT. THE PREEXISTING MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT ADJUSTED OR REMOVED. THE PATIENT NOW HAS FIVE IMPLANTS IN HER RIGHT SI JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 10684764 ↗
• InjurySep 4, 2020Malposition 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 TO A DIFFERENT SURGEON WITH COMPLAINTS OF ONGOING SI JOINT PAIN. THE SURGEON DETERMINED MICRO MOTION OF THE SI JOINT AND THAT THE INITIAL IMPLANTS WERE NOT LOOSE BUT POSSIBLY PLACED TOO POSTERIORLY. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE IMPLANT WITH CHISELS AND INSTALLED A LARGER IMPLANT OF THE SAME TYPE IN A MORE ANTERIOR POSITION. HE THEN ADDED ADDITIONAL HARDWARE AND BONE GRAFT 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 10495281 ↗
• InjuryNov 4, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF LEFT SIDE RADICULAR PAIN. THE SURGEON THOUGHT THAT THE SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR 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 9272369 ↗
• InjuryAug 19, 2019Malposition of Device; 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 NOT PLACED OPTIMALLY, AND THE PATIENT WANTED IT REMOVED. IN (B)(6) 2019, THE SURGEON REMOVED THE CAUDAL POSITIONED IMPLANT. 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 8907538 ↗
• InjuryMay 1, 2019Adverse 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) 2012 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF NO PAIN RELIEF AND REQUESTED THAT THE IMPLANTS BE REMOVED. THE SURGEON DID NOT INDICATE THAT THE IMPLANTS WERE MALPOSITIONED OR LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED ALL THE IMPLANTS USING CHISELS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8571542 ↗
• InjuryJan 26, 2018Adverse 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) 2014 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD INITIAL PAIN RELIEF FOLLOWING THE PROCEDURE BUT LATER COMPLAINED OF A RECURRENCE OF PAIN. THE SURGEON THOUGHT THE MIDDLE IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MIDDLE IMPLANT USING CHISELS BECAUSE THE IMPLANT WAS SOLIDLY FIXED IN BONE. HE REPLACED IT WITH A LARGER IFUSE IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 7222480 ↗
• InjuryNov 30, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED OUT THE MIDDLE IMPLANT A FEW MILLIMETERS TO ALLEVIATE THE NERVE IMPINGEMENT. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7073450 ↗
• InjuryAug 21, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED ON EACH SIDE. THE PATIENT COMPLAINED OF RIGHT SIDE PAIN UPON AWAKENING FROM THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED RIGHT SIDE IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. THE PATIENT WANTED ALL RIGHT-SIDE IMPLANTS REMOVED. IN (B)(6) 2016, THE SURGEON REMOVED ALL RIGHT-SIDE IMPLANTS. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6809058 ↗
• InjuryAug 21, 2017Adverse 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) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT WAS PAIN FREE FOR SIX WEEKS, BUT REPORTED PAIN AFTER TWISTING HER BACK. THE SURGEON SAW NO EVIDENCE OF MALPOSITIONING OR LOOSENING OF ANY OF THE IMPLANTS ON CT SCANS AND WAS NOT SURE IF THE IMPLANTS WERE THE PAIN GENERATOR, BUT DECIDED TO REMOVE THE SUPERIOR POSITIONED IMPLANT ANYWAY. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST SUPERIOR POSITIONED IMPLANT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Pain

  MAUDE report 6809056 ↗
• InjuryJul 17, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD INITIAL BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2017. THE PATIENT LATER COMPLAINED OF LEFT LEG PAIN AND WAS ADMITTED TO THE HOSPITAL WITH A HEMATOMA AT THE LEFT SIDE INCISION. TEN DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST SUPERIOR IMPLANT ON THE LEFT SIDE AND PLACED A NEW IMPLANT OF THE SAME SIZE AND TYPE IN A MORE POSTERIOR POSITION. HE ALSO DRAINED AND FLUSHED THE MINOR HEMATOMA. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT YET KNOWN.

  Patient problems: Hematoma; Undesired Nerve Stimulation

  MAUDE report 6720114 ↗
• InjuryMay 16, 2017Malposition of Device; Malposition of Device

  IN (B)(6) 2017, THE SURGEON WAS PERFORMING AN SI JOINT ARTHRODESIS ON THE PATIENT WHEN THE THIRD IMPLANT WAS PLACED TOO ANTERIORLY. CT SCANS CONFIRMED THAT THE IMPLANT ENTERED THE ABDOMEN BUT DID NOT VIOLATE ANY MAJOR STRUCTURES AND IT WAS REMOVED INTRAOPERATIVELY. THERE WERE NO POST-OP COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568911 ↗
• InjuryMay 5, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR ABOUT TWO MONTHS, BUT LATER COMPLAINED OF LEG PAIN. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT MAY HAVE BEEN IRRITATING THE NEUROFORAMEN. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT YET KNOWN.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 6549410 ↗
• InjuryDec 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2013, THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS WHERE TWO IMPLANTS WERE PLACED. IN (B)(6) 2016 THE PATIENT HAD AN ADDITIONAL IMPLANT ADDED TO HER LEFT SI JOINT. IN (B)(6) 2016, IT WAS LEARNED THAT THE PATIENT DEVELOPED A GLUTEAL HEMATOMA AND GLUTEAL ARTERY PSEUDOANEURYSM IN (B)(6) 2016, AFTER THE ADDITIONAL IMPLANT PROCEDURE. THE PSEUDOANEURYSM WAS COILED AND THE HEMATOMA WAS IRRIGATED AND DEBRIDED. NO IMPLANTS WERE REMOVED. THE PATIENT SUFFERED NO PERMANENT SEQUELAE AND WAS BETTER AFTER THE PROCEDURE.

  Patient problems: Hematoma; Pseudoaneurysm

  MAUDE report 6149363 ↗
• InjuryNov 7, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. DURING THE PROCEDURE, THE SECOND IMPLANT WAS ACCIDENTALLY ADVANCED INTO THE NEUROFORAMEN WHEN INSTALLING THE THIRD IMPLANT DUE TO O-ARM NAVIGATION ERRORS. LATER THAT SAME DAY, THE SURGEON PERFORMED A REVISION SURGERY WHERE THE SECOND IMPLANT WAS REMOVED AND REPLACED WITH A WIDER IMPLANT OF THE SAME LENGTH. THE SURGEON CONFIRMED PROPER POSITIONING OF THE NEW IMPLANT. THE THIRD IMPLANT WAS NOT REPLACED. THE PATIENT IS DOING FINE FOLLOWING THE REVISION SURGERY.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified)

  MAUDE report 6082794 ↗
• InjuryOct 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2016, THE PATIENT UNDERWENT A LEFT 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 CT SCANS THAT THE MOST CRANIAL IMPLANT WAS PLACED TOO POSTERIORLY AND WAS NOT FULLY SEATED IN THE SACRUM. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST CRANIAL IMPLANT. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION SURGERY.

  Patient problems: Arthralgia; Joint Disorder

  MAUDE report 6042297 ↗
• InjuryMar 11, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF SHARP PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED THAT THE SUPERIOR IMPLANT HAD BREACHED THE NEUROFORAMEN. SEVERAL HOURS AFTER THE INITIAL SURGERY, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE BREACHING IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT IN A DIFFERENT POSITION. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION SURGERY AND WAS "DOING VERY WELL."

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

  MAUDE report 5495614 ↗
• InjuryFeb 23, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT PRESENTED TO THE SURGEON A FEW WEEKS LATER WITH KNEE COMPLAINTS THAT SHE DID NOT HAVE BEFORE. THE SURGEON DETERMINED THAT ONE OF THE IMPLANTS WAS NOT FULLY ACROSS THE SI JOINT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE SHE REMOVED THE MIDDLE IMPLANT THAT WAS NOT FULLY CROSSING THE SI JOINT AND ADDED TWO ADDITIONAL IMPLANTS. NO OTHER PRE-EXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT YET KNOWN.

  Patient problems: Joint Disorder; Pain

  MAUDE report 5455460 ↗
• InjuryDec 3, 2015Malposition of Device

  IN (B)(6) 2014 THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED THAT HER ORIGINAL PAIN HAD NOT GONE AWAY. THE SURGEON DETERMINED THAT THE MOST INFERIOR IMPLANT HAD NOT BEEN SUFFICIENTLY ADVANCED ACROSS THE SI JOINT LEADING TO POOR FIXATION. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST INFERIOR IMPLANT USING THE GUIDED REMOVAL SYSTEM AND CHISELS BECAUSE THE IMPLANT WAS SOLIDLY SET IN BONE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Arthralgia; Joint Disorder

  MAUDE report 5265501 ↗
• InjuryOct 28, 2015Positioning Problem

  IN (B)(6) 2015, THE PATIENT UNDERWENT AN SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR LAG PAIN FOLLOWING THE PROCEDURE. THE SURGEON THOUGHT THAT THE MOST SUPERIOR IMPLANT MIGHT BE CAUSING RADICULAR PAIN. ONE MONTH LATER, IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT AND THEN ADDED ANEW IMPLANT IN A MORE INFERIOR LOCATION. THE PATIENT'S PAIN COMPLAINTS ARE BELIEVED TO HAVE RESOLVED.

  Patient problems: Pain

  MAUDE report 5185563 ↗