iFuse Implant System 7045M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00851085007350), received between Apr 3, 2018 and Jul 8, 2022 — classified as 25 injuries.

The most frequently reported specific device problem is “Malposition of Device” (20 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2022, THE SURGEON WAS PERFORMING A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT WHEN HE ENCOUNTERED SIGNIFICANT BLEEDING AFTER BROACHING/IMPACTING FOR THE SECOND IMPLANT. THE SGA OR A BRANCH WAS POSSIBLY DAMAGED. A SINGLE IMPLANT WAS PLACED ADEQUATELY. WHEN THE INSTRUMENTS WERE REMOVED, THE SURGEON OBSERVED EXCESSIVE BLEEDING. PATIENT UNDERWENT COIL EMBOLIZATION OF BRANCH OF THE SGA BY ANOTHER PHYSICIAN. A WEEK LATER, TWO MORE IMPLANTS WERE PLACED WITHOUT INCIDENT. THIS IS A LOW OCCURENCE EVENT AT <.04% OF ALL PROCEDURES PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14962187 ↗
• InjuryNov 23, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF LEG PAIN POST-OP. THE MIDDLE IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE 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 12862358 ↗
• InjuryJul 26, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT HAD PAIN RELIEF FOR TWO WEEKS BEFORE REPORTING LEFT LEG PAIN. MRI IMAGING SUGGESTED THAT THE SUPERIOR IMPLANT WAS PROTRUDING ANTERIORLY EVEN THOUGH CT SCANS LOOKED GOOD. THE SURGEON WASN'T SURE IF THE IMPLANTS WERE THE PAIN GENERATOR OR NOT BUT DECIDED TO BACK UP THE SUPERIOR LEFT SIDE IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED-UP, BUT DID NOT REMOVE, THE LEFT SIDE SUPERIOR POSITIONED IMPLANT FIVE MILLIMETERS TO RELIEVE ANY POSSIBLE NERVE IMPINGEMENT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S LEFT SIDE LEG PAIN SYMPTOMS IMPROVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12225572 ↗
• InjuryJun 8, 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 LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF CONTINUED SI JOINT PAIN. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS MALPOSITIONED TOO ANTERIOR AND INFERIOR AND WAS NOT PROVIDING ADEQUATE FIXATION. IN (B)(6) 2021, THE SURGEON REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. BONE GRAFT WAS PLACED IN THE EXPLANT VOID. THE SURGEON THEN INSTALLED A LONGER IMPLANT OF THE SAME TYPE IN A MORE SUPERIOR AND POSTERIOR POSITION. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 11962684 ↗
• InjuryMay 11, 2021Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD GOOD SI JOINT RELIEF FOLLOWING THE INITIAL PROCEDURE, BUT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS AFTER HIP REPLACEMENT SURGERY. THE SURGEON DETERMINED POSSIBLE LOOSENING OF THE MIDDLE AND INFERIOR POSITIONED IMPLANTS. 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, AND INSTALLED A NEW, WIDER, IMPLANT OF THE SAME TYPE IN THE EXPLANT VOID. THE EXPLANTED IMPLANT HAD VERY GOOD BONE ON-GROWTH. HE THEN ATTEMPTED TO REMOVE THE MIDDLE POSITIONED IMPLANT, BUT IT WAS ALSO SOLIDLY FIXED IN BONE AND WOULD NOT MOVE, SO HE LEFT IT IN PLACE. 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 11809854 ↗
• InjuryMay 3, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD STAGED BILATERAL SI JOINT ARTHRODESIS WITH THE RIGHT SIDE BEING PERFORMED IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED RIGHT SIDE RADICULAR PAIN. THE PATIENT WAS REFERRED TO A DIFFERENT SURGEON WHO DETERMINED THAT THE MIDDLE IMPLANT ON THE RIGHT SIDE HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE MIDDLE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN INSTALLED A NEW, SHORTER IMPLANT OF THE SAME TYPE INTO 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: Undesired Nerve Stimulation

  MAUDE report 11766962 ↗
• InjuryApr 20, 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 INITIALLY BEFORE REPORTING TO A NEW SURGEON WITH COMPLAINTS OF A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM AND WAS IRRITATING THE TISSUES AROUND THE PROXIMAL END OF THE IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN ADDED DIFFERENT HARDWARE INTO 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 11694923 ↗
• InjuryDec 1, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED RADICULAR PAIN COMPLAINTS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON BACKED-UP, BUT DID NOT REMOVE, THE SUPERIOR POSITIONED IMPLANT A COUPLE MILLIMETERS TO RELIEVE THE NERVE IMPINGEMENT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED, AND NO NEW HARDWARE WAS ADDED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10925617 ↗
• InjuryNov 20, 2020Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS LOOSE AND TOO PROUD OF THE ILIUM. IN (B)(6) 2020, THE SURGEON REMOVED THE INFERIOR POSITIONED IMPLANT AND FILLED THE EXPLANT VOID WITH BONE GRAFT. 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 10880513 ↗
• InjuryNov 17, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT INITIALLY HAD SI JOINT PAIN RELIEF BUT REPORTED LEFT SIDE RADICULAR PAIN SHORTLY AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS TOO LONG AND WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE USING THE EXPLANT VOID. HE THEN ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE TO THE LEFT SI JOINT. THE PREEXISTING CRANIAL POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT NOW HAS THREE IMPLANTS IN HER LEFT SI JOINT. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10856107 ↗
• InjuryOct 23, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD STAGED BILATERAL SI JOINT ARTHRODESIS WITH THE LEFT SIDE BEING PERFORMED IN (B)(6) 2018 AND THE RIGHT IN (B)(6) 2018. THREE IMPLANTS WERE INSTALLED IN EACH SIDE. THE PATIENT INITIALLY HAD SI JOINT PAIN RELIEF FOLLOWING THE LEFT SIDE PROCEDURE BUT LATER REPORTED LEFT SIDE RADICULAR PAIN AFTER THE RIGHT SIDE PROCEDURE. IT WAS DETERMINED THAT THE LEFT SIDE INFERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. THE PATIENT WAS REFERRED TO A DIFFERENT SURGEON FOR REVISION OF THE LEFT SIDE.IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE INFERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN INSTALLED A NEW, SHORTER AND WIDER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS ON EITHER SIDE WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10727830 ↗
• InjuryOct 15, 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 REPORTED RIGHT SIDE RADICULAR LEG PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT WAS ADDED TO THE EXPLANT VOID AND NO NEW HARDWARE WAS INSTALLED. 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 10684801 ↗
• InjuryAug 18, 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 RADICULAR LEG PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, 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 10420509 ↗
• InjuryJun 16, 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'S SI JOINT PAIN RESOLVED BUT HE COMPLAINED OF LEFT LEG PAIN FOUR DAYS LATER. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE SHE REMOVED THE IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. 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 10160519 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON WAS PERFORMING A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT IN (B)(6) 2019 WHEN HE ENCOUNTERED VENOUS BLEEDING AFTER THE PLACEMENT OF THE FIRST IMPLANT. THE SURGEON USED PRESSURE, THROMBOTIC MATERIAL AND HEMOSTATIC SEALING TO CONTROL THE BLEEDING. THE SURGEON ABORTED THE PROCEDURE AFTER ADDING ONLY ONE OF THREE IMPLANTS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE PATIENT HAD NO NEW NEUROLOGIC FINDINGS OF NUMBNESS OR WEAKNESS, SPECIFICALLY NO WEAKNESS OF THE GLUTEUS MUSCULATURE. THE PATIENT DID NOT REQUIRE A TRANSFUSION. THE PATIENT WAS DISCHARGED TO HOME THE FIRST POST-OPERATIVE DAY. THIS IS A LOW FREQUENCY, LOW SEVERITY CASE. THE PATIENT SUFFERED NO PERMANENT INJURY. IN (B)(6) 2019, THE SURGEON PERFORMED AN ADDITIONAL PROCEDURE TO ADD THREE ADDITIONAL IMPLANTS OF THE SAME TYPE TO THE LEFT SI JOINT. NO UNUSUAL BLEEDING OCCURRED DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9753535 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON WAS PERFORMING A RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHEN HE NOTICED SIGNIFICANT BLEEDING FROM THE WOUND SITE. BLEEDING WAS FOUND BY IR TO BE COMING FROM THE SUPERIOR GLUTEAL ARTERY. THE PATIENT HAS A PREVIOUSLY INSTALLED SPINAL CORD STIMULATOR IN THE RIGHT GLUTEAL REGION. THE SURGEON USED THE AQUAMANTYS (HEMOSTATIC SEALING DEVICE) TO LOCATE AND CAUTERIZE THE BLEED. BLOOD LOSS WAS ESTIMATED TO BE AROUND 1.5 L. THE PATIENT RECEIVED 2 UNITS OF RBCS IN TRANSFUSION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE SURGICAL INCISION WAS CLOSED, AND THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. THE IMPLANT WAS LEFT IN PLACE. NO ADDITIONAL IMPLANTS WERE PLACED. THIS IS A CASE OF VASCULAR INJURY (A BRANCH OF THE SUPERIOR GLUTEAL ARTERY). IT IS UNUSUAL FOR A SURGEON TO EXPERIENCE THIS TYPE OF INJURY WITH PLACEMENT OF THE MOST CEPHALAD IMPLANT. THE BRANCHES OF THE SUPERIOR GLUTEAL ARTERY BECOME SMALLER AS THEY ARBORIZE IN A CEPHALAD DIRECTION IN THE GLUTEAL MUSCULATURE. THIS IS A LOW FREQUENCY OCCURRENCE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9673284 ↗
• InjuryFeb 5, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD CONTINUED PAIN COMPLAINTS AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED NON-UNION OF THE INFERIOR POSITIONED IMPLANT POSSIBLY RELATED TO THE PATIENT'S POOR HEALTH (SMOKER). THE SURGEON DID NOT INDICATE THAT ANY OF THE PREEXISTING IMPLANTS WERE MALPOSITIONED. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE THE INFERIOR POSITIONED IMPLANT WAS REMOVED USING CHISELS. THE EXPLANT VOID WAS FILLED WITH BONE GRAFT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 9673046 ↗
• InjuryDec 12, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED RIGHT SIDE RADICULAR PAIN SHORTLY AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED UP THE IMPLANT A FEW MILLIMETERS, BUT DID NOT REMOVE IT, 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 9458340 ↗
• InjuryNov 26, 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 SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED UP THE IMPLANT A FEW MILLIMETERS, BUT DID NOT REMOVE IT, TO RELIEVE THE IMPINGEMENT. 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 9376460 ↗
• InjuryMay 30, 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 COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED RIGHT-SIDE IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED RIGHT-SIDE IMPLANT AND FILLED THE EXPLANT VOID WITH BONE GRAFT. HE THEN ADDED ONE ADDITIONAL IMPLANT OF THE SAME TYPE IN A MORE POSTERIOR POSITION TO HELP FIXATE THE JOINT. THE PATIENT APPEARED TO BE DOING WELL FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8656387 ↗
• InjuryApr 2, 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 HAD JOINT PAIN RELIEF FOLLOWING THE PROCEDURE BUT COMPLAINED OF NEW RADICULAR PAIN. THE SURGEON DETERMINED VIA CT SCAN THAT WHILE THE MIDDLE POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING A BONE FRAGMENT TO IMPINGE ON THE NERVE ROOT. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT AND THEN REMOVED THE BONE FRAGMENT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

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

  MAUDE report 8473594 ↗
• InjuryJan 17, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE TWO IMPLANTS WERE PLACED. THE PATIENT DID WELL INITIALLY, BUT LATER REPORTED RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT HAD BREACHED THE SACRUM AND HAD IMPINGED ON THE NERVE ROOT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND ADDED A ILIOSACRAL SCREW IN A DIFFERENT POSITION. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8259118 ↗
• InjuryOct 5, 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 DID WELL AFTER THE INITIAL PROCEDURE BUT COMPLAINED OF PAIN AFTER A FALL THREE WEEKS POST-OP. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT HAD BEEN ADVANCED INTO THE NEUROFORAMEN AFTER THE FALL. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND PLACED A NEW IMPLANT OF THE SAME TYPE BETWEEN THE S1 AND S2 NEUROFORAMEN. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Fall; Undesired Nerve Stimulation

  MAUDE report 7938400 ↗
• InjuryAug 16, 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 REPORTED PAIN COMPLAINTS. THE MOST SUPERIOR IMPLANT WAS MALPOSITIONED AND LIKELY IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND FILLED THE EXPLANT VOID WITH BONE GRAFT. 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 7789706 ↗
• InjuryApr 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 COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT HAD BREACHED THE S1 NEUROFORAMEN. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE BREACHING IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7392778 ↗