iFuse Implant System 7040M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00851085007343), received between May 3, 2018 and Jan 6, 2022 — classified as 22 injuries.

The most frequently reported specific device problem is “Malposition of Device” (18 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2022Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SI JOINT ARTHRODESIS ON (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS NOT POSITIONED FULLY ACROSS THE SI JOINT. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER ONE. HE ALSO ADDED ANOTHER IMPLANT BETWEEN THE SUPERIOR AND MIDDLE IMPLANTS. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 13173915 ↗
• InjuryDec 22, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT POSITIONED FULLY ACROSS THE SI JOINT. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANTS AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE ALSO IMPACTED THE SECOND IMPLANT FURTHER ACROSS JOINT. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS WERE REDUCED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 13064285 ↗
• InjuryJun 2, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS TOO POSTERIOR AND IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. BONE WAX WAS PLACED IN THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO NEW HARDWARE WAS ADDED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11925918 ↗
• InjuryMay 19, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF LEG PAIN THE FOLLOWING DAY. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE THE INFERIOR POSITIONED IMPLANT WAS REMOVED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO NEW HARDWARE WAS ADDED. IT IS NOT KNOWN IF BONE GRAFT WAS PLACED IN THE EXPLANT VOID. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11849941 ↗
• InjuryMar 30, 2021Malposition of Device; Migration; Malposition of Device; Migration

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE, BUT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS NOT FULLY ACROSS THE SI JOINT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT. THERE WAS BONY GROWTH ON THE EXPLANT. NO BONE GRAFT WAS PLACED INTO THE EXPLANT VOID. HE THEN INSTALLED A LONGER IMPLANT OF THE SAME TYPE IN A DIFFERENT POSITION. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 11591186 ↗
• InjuryMar 1, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE, BUT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS MALPOSITIONED TOO POSTERIORLY, NOT FULLY IN BONE AND TOO PROUD OF THE ILIUM. IN (B)(6) 2021, THE SURGEON REMOVED THE INFERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 11395936 ↗
• InjuryJan 27, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED CONTINUED PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS SLIGHTLY TOO PROUD OF THE ILIUM AND IRRITATING THE SURROUNDING TISSUE. IN (B)(6) 2020, THE SURGEON PERFORMED AN OPEN PROCEDURE WHERE HE REMOVED A PORTION OF THE PSIS AND A SMALL BIT OF THE PROXIMAL END OF THE SUPERIOR POSITIONED IMPLANT WITH A BURR. HE THEN PACKED THE JOINT WITH BONE GRAFT AND CLOSED. 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 11240489 ↗
• InjuryDec 10, 2020Adverse 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) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF A RECURRENCE OF RIGHT SI JOINT PAIN SYMPTOMS. THERAPEUTIC INJECTIONS INTO THE CAUDAL PORTION OF THE SI JOINT YIELDED COMPLETE PAIN RELIEF. IMAGING DID NOT SHOW THAT THE CAUDAL POSITIONED IMPLANT WAS LOOSE OR MALPOSITIONED. THE SURGEON WAS NOT SURE IF THE CAUDAL POSITIONED SI JOINT IMPLANT WAS THE PAIN GENERATOR BUT DECIDED TO REMOVE IT ANYWAY. IN (B)(6) 2020, THE SURGEON REMOVED THE CAUDAL POSITIONED IMPLANT USING CHISELS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. HE THEN ADDED DIFFERENT HARDWARE TO THE SI JOINT AND PACKED THE JOINT WITH BONE GRAFT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 10985834 ↗
• InjuryOct 8, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED ON THE LEFT SIDE AND ONE ON THE RIGHT. THE PATIENT REPORTED LEFT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE LEFT SIDE SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. EIGHT DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE 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 10653307 ↗
• InjuryAug 18, 2020Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Inadequacy of Device Shape and/or Size; Loss of Osseointegration

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF LEFT SIDE SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED LOOSENING OF THE INFERIOR POSITIONED IMPLANT BASED ON HALOING SEEN ON IMAGING. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT. HE THEN INSTALLED A WIDER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 10420379 ↗
• InjuryAug 11, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT COMPLAINED OF RIGHT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE RIGHT SIDE CAUDAL POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE PULLED BACK THE RIGHT SIDE CAUDAL POSITIONED IMPLANT APPROXIMATELY ONE CENTIMETER TO RELIEVE THE IMPINGEMENT. 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 10393298 ↗
• InjuryJun 2, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT'S SI JOINT PAIN RESOLVED FOR FOUR MONTHS BEFORE COMPLAINING OF RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS MALPOSITIONED ANTERIORLY AND IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING OSTEOTOMES AS IT WAS SOLIDLY FIXED IN BONE. THE EXPLANT VOID WAS FILLED WITH FLOSEAL. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE AND SIZE IN A MORE OPTIMAL 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 10112637 ↗
• InjuryMar 30, 2020Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT WAS MALPOSITIONED AND IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT. THERE WAS SIGNIFICANT BONE GROWTH ON THE REMOVED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED NO OTHER HARDWARE OR BONE GRAFT WAS ADDED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9901546 ↗
• InjuryDec 12, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF LEFT SIDE HIP PAIN. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM CAUSING PAIN IN THE SURROUNDING TISSUE. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 9457995 ↗
• InjuryNov 26, 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 RIGHT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2019 THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED USING CHISELS. 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 9376201 ↗
• InjuryOct 24, 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 LATER COMPLAINED OF LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE USED CHISELS TO RELEASE THE MIDDLE IMPLANT FROM THE BONE AND BACKED IT UP LESS THAN ONE CENTIMETER TO RELIEVE THE IMPINGEMENT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9234490 ↗
• InjuryJan 29, 2019Inadequacy of Device Shape and/or Size; Failure to Osseointegrate; Inadequacy of Device Shape and/or Size; Failure to Osseointegrate

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF A NEW SI JOINT PAIN. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS TOO SHORT AND NOT FULLY ACROSS THE SI JOINT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN THE ILIUM. NO OTHER PREEXISTING SI JOINT IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 8285304 ↗
• InjuryJan 4, 2019Malposition of Device; Malposition of Device

  THIS REVISION WAS DISCOVERED DURING AN INVESTIGATION INTO A PATIENT'S PAIN COMPLAINTS THAT WERE REPORTED IN (B)(6) 2018. THE PERFORMING SURGEON DID NOT REPORT THE REVISION TO THE MANUFACTURER. THE PATIENT HAD 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 PERFORMED A REVISION PROCEDURE IN (B)(6) 2017 WHERE HE BACKED UP THE MIDDLE IMPLANT A FEW MILLIMETERS TO ALLEVIATE POSSIBLE NERVE IMPINGEMENT. THE PATIENT REPORTS LINGERING LEFT SIDE RADICULAR PAIN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8220181 ↗
• InjurySep 10, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAS A DYSMORPHIC SACRUM. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS HAVE REDUCED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7861164 ↗
• InjuryAug 16, 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) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD PAIN RELIEF FOR THREE MONTHS BEFORE COMPLAINING ABOUT A RECURRENCE OF PAIN AFTER A FALL. THE SURGEON THOUGHT THAT THE INFERIOR POSITIONED IMPLANT MAY HAVE "BACKED OUT" ALTHOUGH IT APPEARED TO BE OPTIMALLY POSITIONED. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT. THE EXPLANTED IMPLANT HAD SIGNIFICANT BONY INGROWTH ON ALL SIDES. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia; Fall

  MAUDE report 7789806 ↗
• InjuryJul 19, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF BUTTOCK PAIN. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT WAS MALPOSITIONED AND DID NOT FULLY CROSS THE SI JOINT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MIDDLE IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND REPLACED IT WITH A NEW LARGER IFUSE IMPLANT IN THE EXPLANT VOID TO HELP FIXATE THE SI 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 7703099 ↗
• InjuryMay 3, 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 LATER COMPLAINED OF RIGHT SI JOINT PAIN. THE SURGEON DETERMINED THAT THE MOST CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED AND LIKELY DID NOT CROSS THE SI JOINT DUE TO INCORRECT INITIAL IMAGING. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT AND PLACED A NEW IFUSE IMPLANT IN A MORE POSTERIOR POSITION. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 7484571 ↗