iFuse Implant System 7060-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00859256003323), received between Oct 2, 2015 and May 30, 2019 — classified as 17 injuries.

The most frequently reported specific device problem is “Malposition of Device” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. 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 8656450 ↗
• InjuryDec 20, 2018Malposition 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 INITIAL SI JOINT PAIN RELIEF BEFORE COMPLAINING OF RADICULAR PAIN. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8187578 ↗
• InjuryDec 20, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE TWO IMPLANTS WERE PLACED. THE PATIENT DID WELL FOR SEVERAL MONTHS FOLLOWING THE INITIAL PROCEDURE BUT LATER COMPLAINED OF A RECURRENCE OF BACK PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT USING CHISELS AND REPLACED IT WITH A WIDER IMPLANT OF THE SAME TYPE. THE SURGEON DID NOT ADJUST OR REMOVE THE SECOND PREEXISTING IMPLANT. HE THEN ADDED AN ADDITIONAL IMPLANT BETWEEN THE TWO EXISTING IMPLANTS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8184843 ↗
• InjurySep 26, 2018Malposition of Device; Malposition of Device

  THIS PREVIOUSLY UNREPORTED REVISION WAS DISCOVERED IN AN UNRELATED ANALYSIS OF RECORDS. THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE TWO IMPLANTS WERE PLACED. IT IS NOT KNOWN IF THE PATIENT HAD ANY PAIN COMPLAINTS. IN (B)(6) 2018, THE SURGEON THOUGHT THAT THE SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN ENCROACHING ON THE NEUROFORAMEN AND DECIDED TO REMOVE IT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE FIRST REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. HE THEN ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE IN A MORE INFERIOR 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 7911675 ↗
• InjuryJan 2, 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'S SI JOINT PAIN RESOLVED FOLLOWING THE PROCEDURE, BUT LATER COMPLAINED OF RADICULAR PAIN. 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 REMOVED THE MIDDLE IMPLANT AND REPLACED IT WITH A SHORTER IFUSE IMPLANT. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7157514 ↗
• InjuryOct 17, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD A PERIOD OF PAIN RELIEF BEFORE PRESENTING TO A DIFFERENT SURGEON WITH A RECURRENCE OF LEFT SIDE PAIN. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED LEFT SIDE IMPLANT WAS BREACHING THE NEUROFORAMEN. IN (B)(6) 2017, THE SURGEON REMOVED THE CRANIAL IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6955239 ↗
• InjuryOct 12, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE TWO IMPLANTS WERE PLACED. THE PATIENT HAS A DYSMORPHIC SACRUM THAT MADE INTRAOPERATIVE IMAGING OF THE SI JOINT DIFFICULT. THE PATIENT HAD SI JOINT RELATED PAIN RELIEF, BUT COMPLAINED OF PAIN (RADICULOPATHY) FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE FIRST IMPLANT WAS IMPINGING ON A NERVE. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE BACKED OUT THE FIRST IMPLANT TO ALLEVIATE THE NERVE IMPINGEMENT. THE PATIENT'S PAIN RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6946147 ↗
• InjuryAug 16, 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 LATER COMPLAINED OF LEG PAIN. THE IMPLANTS HAD NOT BREACHED THE NEUROFORAMEN, BUT THE SURGEON THOUGHT THAT BONE CHIPS MAY HAVE BEEN IRRITATING THE NERVE. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS APPEAR TO HAVE RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 6799180 ↗
• InjuryMar 2, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE TWO IMPLANTS WERE PLACED. AFTER AN UNKNOWN PERIOD OF PAIN RELIEF, THE PATIENT PRESENTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF LEFT SIDE SI JOINT PAIN. THE NEW SURGEON DETERMINED VIA X-RAYS THAT THE CEPHALAD IMPLANT WAS APPROXIMATELY 15 MILLIMETERS PROUD OF THE ILIUM AND WAS IRRITATING THE TISSUE AROUND THE PROXIMAL END OF THE IMPLANT. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CEPHALAD IMPLANT. THE CAUDAL IMPLANT WAS LEFT IN PLACE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Pain

  MAUDE report 6373469 ↗
• InjuryNov 1, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A BILATERAL SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED ON EACH SIDE. THE PATIENT REPORTED RIGHT LEG PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED THAT THE MOST CRANIAL RIGHT SIDE IMPLANT HAD BREACHED THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. A FEW DAYS 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 RESOLVED FOLLOWING THE REVISION SURGERY.

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

  MAUDE report 6069655 ↗
• InjuryNov 1, 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 REPORTED RADICULAR PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED THAT THE MOST CRANIAL IMPLANT WAS ENCROACHING ON THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE THE CRANIAL IMPLANT WAS REMOVED AND REPLACED WITH A SHORTER 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 6069211 ↗
• InjurySep 23, 2016Malposition 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 LEG PAIN AFTER THE INITIAL SURGERY. THE SURGEON DETERMINED THAT THE RIGHT SIDE SUPERIOR IMPLANT WAS MALPOSITIONED AND WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE RIGHT SIDE 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 5973533 ↗
• InjuryJul 1, 2016Malposition of Device; Malposition of Device

  THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR PAIN AFTER THE INITIAL SURGERY. THE SURGEON THOUGHT THAT THE MOST CEPHALAD IMPLANT MAY HAVE BEEN IMPINGING OR BREACHING THE NEUROFORAMEN. THE DAY AFTER THE INITIAL SURGERY, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST CEPHALAD IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE SURGEON REPORTED THAT THE PATIENT WAS DOING WELL FOLLOWING THE REVISION SURGERY.

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

  MAUDE report 5764867 ↗
• InjuryMay 31, 2016Malposition of Device; Malposition of Device

  THE PATIENT HAD A RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED. THE SURGEON LATER DETERMINED THAT THE MOST SUPERIOR IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

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

  MAUDE report 5688475 ↗
• InjuryJan 15, 2016Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2014 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF LEG PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST SUPERIOR IMPLANT WAS TOO PROUD OF THE ILIUM AND CLOSE TO THE PROXIMAL ALA. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT. NO OTHER EXISTING IMPLANTS WERE REMOVED OR ADJUSTED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Arthralgia; Joint Disorder

  MAUDE report 5369908 ↗
• InjuryOct 8, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE TWO IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF LEG PAIN THE FOLLOWING DAY. A CT SCAN SUGGESTED THAT THE SUPERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE RETRACTED THE SUPERIOR IMPLANT ON THE RIGHT SIDE APPROXIMATELY TWO TO THREE MILLIMETERS TO RELIEVE THE IMPINGEMENT. NO IMPLANTS WERE REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION.

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

  MAUDE report 5136129 ↗
• InjuryOct 2, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD LEG PAIN FOLLOWING THE PROCEDURE DUE TO THE SUPERIOR IMPLANT POSSIBLY IMPINGING ON THE NEUROFORAMEN. TWO DAYS FOLLOWING THE INITIAL SURGERY, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT IN THE SAME HOLE. THE PATIENT'S PAIN SYMPTOMS RESOLVED AFTER THE REVISION.

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

  MAUDE report 5123777 ↗