iFuse Implant System 7055-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00859256003316), received between Oct 20, 2015 and Dec 7, 2020 — classified as 27 injuries.

The most frequently reported specific device problem is “Malposition of Device” (21 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2020Malposition 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 COMPLAINED OF RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. NO BONE GRAFT OR NEW HARDWARE WAS ADDED TO THE EXPLANT VOID. 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 10962090 ↗
• InjuryMar 20, 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 HAD A LONG PERIOD OF SI JOINT PAIN RELIEF BEFORE REPORTING TO A DIFFERENT SURGEON WITH COMPLAINTS OF A RECURRENCE OF SI JOINT PAIN. 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 MIDDLE POSITIONED IMPLANT USING CHISELS AND REPLACED IT WITH A WIDER IMPLANT OF THE SAME TYPE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT IS DOING WELL AFTER THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 8438841 ↗
• InjuryJan 8, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2014 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF CONTINUED RADICULAR PAIN. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON ATTEMPTED A REVISION PROCEDURE TO REMOVE THE SUPERIOR POSITIONED IMPLANT USING CHISELS. THE IMPLANT WAS SOLIDLY FIXED IN BONE AND AFTER SEVERAL FAILED ATTEMPTS TO REMOVE THE IMPLANT WITH CHISELS, HE DECIDED TO LEAVE ALL THE IMPLANTS IN PLACE. NO IMPLANTS WERE ADJUSTED OR REMOVED. IT IS LIKELY THAT THE PATIENT STILL HAS RADICULAR PAIN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8229334 ↗
• InjuryMar 1, 2018Malposition 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 REPORTED LEG PAIN COMPLAINTS TO THE SURGEON AFTER THE INITIAL PROCEDURE. THE PATIENT LATER PRESENTED TO A DIFFERENT SURGEON WHO DETERMINED THAT MOST SUPERIOR POSITIONED LEFT SIDE IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE WITH HEAVY BONE GROWTH ON THE IMPLANT. HE THEN REPLACED IT WITH A SHORTER IFUSE IMPLANT. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7306669 ↗
• InjuryFeb 20, 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 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. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7283059 ↗
• InjuryFeb 14, 2018Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; 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 HAD SIX MONTHS OF PAIN RELIEF BEFORE REPORTING A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT MAY HAVE BEEN TOO SHORT AND NOT OPTIMALLY POSITIONED ACROSS THE SI JOINT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT USING CHISELS AND PACKED THE EXPLANT VOID WITH BONE GRAFT. HE THEN PLACED A NEW, LONGER, IFUSE IMPLANT PACKED WITH BONE GRAFT IN A NEW POSTERIOR-TO-ANTERIOR/INFERIOR-TO-SUPERIOR TRAJECTORY TO MORE FULLY CROSS AND FIXATE THE SI JOINT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia; Joint Disorder

  MAUDE report 7270075 ↗
• InjuryJan 26, 2018Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; 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 COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. FIVE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia; Undesired Nerve Stimulation

  MAUDE report 7222807 ↗
• InjuryNov 28, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT REPORTED A TINGLING SENSATION IN HER LEG FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7064207 ↗
• InjuryNov 15, 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 COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CRANIAL IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2017, THE SURGEON REMOVED THE MOST CRANIAL IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7034954 ↗
• InjuryOct 18, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN(B)(6) 2017 WHERE FOUR IMPLANTS WERE PLACED. THE PATIENT HAS ABNORMAL SACRAL ANATOMY THAT MADE INTRAOPERATIVE IMAGING OF THE SI JOINT DIFFICULT. THE PATIENT COMPLAINED OF LEG NUMBNESS IMMEDIATELY FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SECOND IMPLANT HAD BREACHED THE NEUROFORAMEN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE BACKED OUT THE SECOND IMPLANT ONE CENTIMETER TO ALLEVIATE THE NERVE IMPINGEMENT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6958004 ↗
• 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) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT REPORTED PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST SUPERIOR IMPLANT. THE PATIENT'S PAIN RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6720016 ↗
• InjuryJul 17, 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 REPORTED RIGHT SIDE RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON COULD NOT MAKE A DEFINITIVE DETERMINATION THAT THE SECOND IMPLANT WAS IMPINGING ON THE NEUROFORAMEN BUT DECIDED TO REMOVE IT ANYWAY. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SECOND IMPLANT AND REPLACED IT WITH A SHORTER AND WIDER IMPLANT OF THE SAME TYPE. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia; Undesired Nerve Stimulation

  MAUDE report 6716979 ↗
• InjuryJun 2, 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) 2012 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 THE CRANIAL POSITIONED IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CRANIAL IMPLANT. THE IMPLANT WAS SOLIDLY FIXED IN BONE AND TOOK CONSIDERABLE EFFORT TO REMOVE WITH CHISELS. HE REPLACED IT WITH A SIMILAR IMPLANT AND BONE GRAFT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT YET KNOWN.

  Patient problems: Arthralgia

  MAUDE report 6609756 ↗
• InjuryMay 19, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR LEG PAIN IMMEDIATELY FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR IMPLANT HAD BREACHED THE NEUROFORAMEN AND CAUSED A SMALL FRACTURE OF THE ILIUM. A FEW HOURS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED COMPLETELY FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Bone Fracture(s); Pain; Undesired Nerve Stimulation

  MAUDE report 6579026 ↗
• InjuryMay 16, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED OF LEG PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR IMPLANT WAS PLACED TOO DEEP AND HAD BREACHED 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 PATIENT SEEMS TO BE DOING BETTER FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 6568918 ↗
• InjuryFeb 10, 2017Malposition of Device; Malposition of Device

  THE PATIENT INITIALLY HAD SI JOINT PAIN RELIEF FOLLOWING INITIAL RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 BUT LATER COMPLAINED OF RADICULAR PAIN. THE SURGEON DETERMINED THAT THE MOST CEPHALAD IMPLANT HAD BREACHED THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CEPHALAD IMPLANT AND FILLED THE EXPLANT HOLE WITH BONE GRAFT. HE THEN PLACED A NEW SHORTER IMPLANT ANTERIOR AND MEDIAL TO THE SECOND AND THIRD EXISTING IMPLANTS. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. 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 6323788 ↗
• InjuryNov 1, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT REPORTED RIGHT LEG PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED THAT THE MOST CRANIAL RIGHT SIDE IMPLANT HAD SLIGHTLY 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 LEG PAIN RESOLVED FOLLOWING THE REVISION SURGERY.

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

  MAUDE report 6069656 ↗
• InjuryOct 11, 2016Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT 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 DETERMINED VIA CT SCAN THAT THE MOST CRANIAL 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 HE BACKED OUT THE MOST CRANIAL IMPLANT A FEW MILLIMETERS TO ALLEVIATE THE NERVE IMPINGEMENT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. 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 6018974 ↗
• InjuryAug 16, 2016Malposition of Device; Malposition of Device

  THE PATIENT HAD A RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR PAIN AFTER THE INITIAL SURGERY. THE PATIENT PRESENTED TO A DIFFERENT SURGEON THAT DETERMINED THAT THE MIDDLE IMPLANT WAS MALPOSITIONED AND POSSIBLY IMPINGING OR BREACHING THE NEUROFORAMEN. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MIDDLE 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 5879258 ↗
• InjuryAug 2, 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 PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED VIA CT SCAN THAT THE MIDDLE IMPLANT WAS IMPINGING ON OR HAD BREACHED THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. THE SURGEON PERFORMED A REVISION SURGERY A FEW WEEKS LATER WHERE HE BACKED OUT THE MIDDLE IMPLANT A FEW MILLIMETERS TO ALLEVIATE THE IMPINGEMENT OR BREACHING. NO IMPLANTS WERE REMOVED. 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 5840225 ↗
• InjuryJun 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2014 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT EXPERIENCED A LONG TERM OF SI JOINT PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE. THE PATIENT RECENTLY (2016) COMPLAINED OF L5 NERVE PAIN. IN (B)(6) 2016, THE SURGEON PERFORMED AN L5 NERVE DECOMPRESSION. HE ALSO REMOVED THE CEPHALAD SI JOINT IMPLANT AS A PRECAUTION EVEN THERE WAS NO INDICATION THAT THE IMPLANT WAS A PAIN GENERATOR. NO OTHER PREEXISTING SI JOINT IMPLANTS WERE ADJUSTED OR REMOVED. 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 5760208 ↗
• InjuryApr 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2015, THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD INITIAL PAIN RELIEF FOLLOWING THE PROCEDURE BUT COMPLAINED OF RADICULAR PAIN A WEEK LATER. THE SURGEON DETERMINED VIA CT SCAN THAT THE IMPLANTS WERE IN THE CORRECT POSITION AND NOT IMPINGING ON ANY NEUROFORAMEN. HE DID DISCOVER THAT THE PATIENT HAD A LUMBOSACRAL TRANSITIONAL VERTEBRAE THAT MAY HAVE BEEN CAUSING NERVE IRRITATION WITH THE MOST SUPERIOR POSITIONED IMPLANT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY ON THE PATIENT'S LEFT SI JOINT WHERE HE REMOVED THE SUPERIOR IMPLANT. THE IMPLANT WAS SOLIDLY FIXED IN THE ILIUM AND REQUIRED CONSIDERABLE EFFORT TO REMOVE IT. THE EXPLANT HOLE WAS NOT FILLED WITH BONE GRAFT. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED COMPLETELY FOLLOWING THE REVISION SURGERY.

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

  MAUDE report 5582187 ↗
• InjuryJan 25, 2016Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT STILL HAD SI JOINT PAIN FOLLOWING THE PROCEDURE AS WELL AS NEW LEG PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT AND FILLED THE EXPLANT HOLE WITH BONE GRAFT. NONE OF THE OTHER IMPLANTS WERE REMOVED OR ADJUSTED. 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 5388804 ↗
• InjuryJan 15, 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 COMPLAINED OF RADICULAR LEG PAIN DOWN HER RIGHT SIDE FOLLOWING THE PROCEDURE. A CT SCAN SHOWED THAT AN IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE BREACHING IMPLANT AND THEN ADDED A SHORTER IMPLANT IN A MORE ANTERIOR POSITION. THE EXPLANT HOLE WAS NOT FILLED WITH BONE GRAFT. 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 5370029 ↗
• InjuryDec 30, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT'S SI JOINT PAIN SYMPTOMS IMPROVED FOLLOWING THE PROCEDURE BUT REPORTED SYMPTOMS OF NERVE ROOT PAIN A FEW WEEKS LATER. CT IMAGES WERE INCONCLUSIVE IN DETERMINING IF THE SUPERIOR IMPLANT HAD BREACHED THE NEUROFORAMEN BUT THE SURGEON DECIDE TO REMOVE THE IMPLANT ANYWAY SINCE NERVE ROOT PAIN SYMPTOMS WERE PRESENT. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT. THE IMPLANT WAS DIFFICULT TO REMOVE AS IT WAS FIXED SOLIDLY IN BONE. NO OTHER IMPLANTS WERE REMOVED OR ADJUSTED. 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 5336836 ↗