iFuse Implant System 7050-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00859256003309), received between Oct 2, 2015 and Oct 14, 2021 — classified as 34 injuries.

The most frequently reported specific device problem is “Malposition of Device” (24 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE NEW SURGEON DETERMINED BASED ON THE IMAGING REPORTS THAT THE MIDDLE-POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IFUSE IMPLANT USING THE IFUSE REMOVAL ADAPTER AS IT WAS SOLIDLY FIXED IN BONE. THE IMPLANT WAS REPLACED WITH A SHORTER 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 12637305 ↗
• InjurySep 10, 2021Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR MANY MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED LOOSENING ON THE SACRAL SIDE OF THE SUPERIOR POSITIONED IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR IMPLANT USING CHISELS. HE THEN INSTALLED NEW, WIDER, IMPLANT OF THE SAME TYPE IN THE EXPLANT VOID. FINALLY, HE INSTALLED A LONGER IMPLANT OF THE SAME TYPE IN A POSITION SUPERIOR TO THE EXISTING IMPLANTS. 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 12457195 ↗
• InjuryJun 17, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF RADICULAR PAIN. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A NEW, SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. FINALLY, HE INSTALLED AN ADDITIONAL IMPLANT OF THE SAME TYPE IN A MORE INFERIOR AND POSTERIOR POSITION. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12021127 ↗
• InjuryMay 14, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF RADICULAR PAIN. THE SURGEON DETERMINED THAT THE RIGHT SIDE INFERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE INFERIOR POSITIONED IMPLANT USING CHISELS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. IT IS NOT KNOWN IF BONE GRAFT WAS ADDED TO THE EXPLANT VOID. NO NEW HARDWARE WAS ADDED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11828904 ↗
• InjuryApr 19, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2021 THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED RIGHT SIDE RADICULAR FOOT PAIN. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE S1 NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. 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 11691317 ↗
• InjuryDec 8, 2020Malposition 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 REPORTED TO A DIFFERENT SURGEON WITH A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS MALPOSITIONED AND NOT ACROSS THE SI JOINT. IN (B)(6) 2020, THE SURGEON REMOVED THE SUPERIOR POSITIONED IMPLANT. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE IN A MORE OPTIMAL POSITION ACROSS THE SI JOINT. NO BONE GRAFT WAS PLACED IN THE EXPLANT VOID. 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 10970844 ↗
• InjuryJul 22, 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 COMPLAINING OF A RECURRENCE OF PAIN AFTER A FALL. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT MAY HAVE BEEN LOOSE BASED ON LUCENCY OBSERVED ON X-RAYS. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND REPLACED IT WITH A LARGER IMPLANT OF THE SAME TYPE USING THE EXPLANT VOID. HE ALSO ADDED ONE ADDITIONAL IMPLANT OF THE SAME TYPE IN A MORE ANTERIOR POSITION TO HELP FIXATE THE SI JOINT. THE PATIENT WAS DOING WELL AFTER THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 8813874 ↗
• InjuryMay 17, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS LOOSE WHILE THE OTHER IMPLANTS WERE SOLIDLY FIXED IN BONE. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE MALPOSITIONED. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND REPLACED IT WITH A WIDER IMPLANT OF THE SAME TYPE USING THE EXPLANT VOID. HE THEN INSTALLED AN ADDITIONAL IMPLANT OF THE SAME TYPE IN MORE ANTERIOR POSITION. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8621448 ↗
• InjuryFeb 22, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2011 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT DID WELL INITIALLY, BUT LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF RADICULAR LEG PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND INSTALLED TWO ADDITIONAL IMPLANTS OF THE SAME TYPE IN NEW POSITIONS TO HELP FIXATE THE JOINT. 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 8364031 ↗
• InjuryJan 31, 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 DID WELL FOR A FEW WEEKS FOLLOWING THE PROCEDURE, BUT LATER REPORTED LEG PAIN. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT WAS TOO LONG AND WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER AND WIDER 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 8294708 ↗
• InjuryJan 31, 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 SI JOINT PAIN RELIEF FOR NINE MONTHS BUT LATER COMPLAINED OF A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE IMPLANT AND REPLACED IT WITH A WIDER IMPLANT OF THE SAME TYPE TO HELP FIXATE THE SI JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8294596 ↗
• InjuryJan 25, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF NO PAIN RELIEF. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND REPLACED IT WITH A WIDER IMPLANT OF THE SAME TYPE. HE THEN INSTALLED AN ADDITIONAL IMPLANT OF THE SAME TYPE IN A NEW POSITION TO HELP FIXATE THE JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 8278063 ↗
• 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) 2016 WHERE THREE IMPLANTS WERE PLACED. IT IS NOT KNOWN IF THE PATIENT HAD ANY PAIN COMPLAINTS. IN (B)(6) 2018, THE SURGEON THOUGHT THAT THE CEPHALAD POSITIONED IMPLANT MAY HAVE BEEN TOO CLOSE TO THE NEUROFORAMEN AND DECIDED TO REMOVE IT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE FIRST REMOVED THE CEPHALAD IMPLANT, LIKELY USING CHISELS. HE THEN ATTEMPTED TO PLACE AN ILIOSACRAL SCREW IN THE EXPLANT VOID BUT THE SCREW BROKE AND WAS SUBSEQUENTLY REMOVED LEAVING THE SCREW WASHER UNNOTICED IN THE VOID. AFTER PLACING A SHORTER IMPLANT OF THE SAME INITIAL TYPE INTO THE VOID, THE SURGEON NOTICED THE WASHER ON INTEROPERATIVE X-RAYS, REMOVED THE IMPLANT AND THE WASHER AND REPLACED THE IMPLANT. HE FINALLY ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE IN A VENTRAL 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 7911570 ↗
• InjuryJul 17, 2018Malposition of Device; Malposition of Device

  DURING AN INVESTIGATION IN JUNE 2018, IT WAS DISCOVERED THAT A PATIENT HAD A PREVIOUSLY UNREPORTED REVISION PROCEDURE IN (B)(6) 2015. THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED. THE SURGEON DETERMINED SHORTLY AFTER THE INITIAL PROCEDURE THAT THE MOST SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NERVE ROOT. APPROXIMATELY TWO WEEKS AFTER THE INITIAL PROCEDURE, 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 7693890 ↗
• InjuryJun 29, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2013 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF A RECURRENCE OF PAIN. IN (B)(6) 2016, AN ADDITIONAL IMPLANT WAS ADDED TO HELP STABILIZE THE JOINT. IN (B)(6) 2018, A DIFFERENT SURGEON REMOVED THE MOST CRANIAL POSITIONED IMPLANT DUE TO POSSIBLE LOOSENING AND REPLACED IT WITH A WIDER IMPLANT OF THE SAME TYPE TO HELP FURTHER FIXATE THE JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 7652646 ↗
• InjuryApr 2, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD SI JOINT PAIN RELIEF, BUT COMPLAINED OF RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED UP, BUT DID NOT REMOVE, THE MIDDLE IMPLANT TO RELIEVE THE IMPINGEMENT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7389338 ↗
• InjuryMar 22, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD SI JOINT PAIN RELIEF BUT COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND PLACED A SHORTER IFUSE IMPLANT IN A NEW POSITION. THE PATIENT'S RADICULAR PAIN IMPROVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7363636 ↗
• InjuryFeb 5, 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 COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND REPLACED IT WITH A SHORTER IFUSE IMPLANT IN A MORE CAUDAL POSITION. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7242917 ↗
• InjuryDec 1, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 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 REMOVED THE MIDDLE IMPLANT AND REPLACED IT WITH A SHORTER IFUSE IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7074969 ↗
• InjuryNov 28, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT REPORTED RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NERVE ROOT. THE SURGEON PERFORMED A REVISION PROCEDURE THE DAY AFTER THE INITIAL SURGERY WHERE HE REMOVED THE IMPLANT. THE PATIENT'S PAIN RESOLVED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7064171 ↗
• InjuryNov 28, 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) 2015 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD PERSISTENT PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON THOUGHT THAT ONE IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND REPLACED IT WITH AN IFUSE IMPLANT. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 7064071 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD A RECURRENCE OF PAIN. IN (B)(6) 2017, THE SURGEON REMOVED THE MOST INFERIOR POSITIONED IMPLANT BUT LEFT TWO IMPLANTS IN PLACE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 7044928 ↗
• InjurySep 22, 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 HAD SI JOINT RELATED PAIN RELIEF, BUT COMPLAINED OF LEG PAIN 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 APPROXIMATELY ONE CENTIMETER TO ALLEVIATE THE NERVE IMPINGEMENT. THE PATIENT'S LEG PAIN RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6888138 ↗
• InjuryDec 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INITIAL RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016. THE PATIENT COMPLAINED OF LEG PAIN SOMETIME AFTER THE INITIAL SURGERY. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE FIRST AND THIRD IMPLANTS THAT HE SUSPECTED WERE IMPINGING ON THE NERVE ROOT, LEAVING THE MIDDLE IMPLANT IN PLACE (PREVIOUSLY REPORTED ON MDR 3007700286-2016-00046). THE PATIENT LATER HAD A RECURRENCE OF PAIN. THE SURGEON THOUGHT THAT THE SOLE REMAINING IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2016, THE SURGEON ATTEMPTED TO REMOVE THE REMAINING IMPLANT, BUT IT WAS SOLIDLY FIXED IN BONE AND COULD NOT BE REMOVED. IT WAS NOT LOOSE. THE SURGEON LEFT THE IMPLANT IN PLACE AND DEBRIDED THE JOINT AND ADDED BONE GRAFT. THE STATUS OF THE PATIENT FOLLOWING THE SURGERY IS NOT YET KNOWN.

  Patient problems: Arthralgia; Pain

  MAUDE report 6182988 ↗
• InjurySep 23, 2016Malposition 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 AN INITIAL PERIOD OF PAIN RELIEF BUT LATER COMPLAINED OF LEG PAIN. THE SURGEON DETERMINED VIA CT SCANS AND NEUROMONITORING THAT THE MOST PROXIMAL IMPLANT HAD BREACHED THE ALA AND WAS SLIGHTLY IMPINGING ON THE NERVE ROOT CAUSING THE LEG PAIN. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE LEFT SIDE PROXIMAL IMPLANT USING CHISELS AS THERE WAS A CONSIDERABLE AMOUNT OF BONE GROWTH ON THE IMPLANT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT IS DOING BETTER FOLLOWING THE REVISION SURGERY.

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

  MAUDE report 5973543 ↗