iFuse Implant System 7060M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00851085007381), received between Jan 2, 2018 and Apr 1, 2022 — classified as 34 injuries.

The most frequently reported specific device problem is “Malposition of Device” (32 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.

• InjuryApr 1, 2022Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2022 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. DURING THE INITIAL PROCEDURE, THE SURGEON HAD REMOVED THE GUIDE PIN DUE TO PIN ADVANCEMENT AND IMPACTED THE IMPLANT INTO POSITION WITHOUT USING ANY GUIDE PIN AT ALL. DURING INSTALLATION, THE IMPLANT DID NOT FOLLOW THE PRESCRIBED PATH. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. THE DAY AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR 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 13984937 ↗
• InjuryDec 21, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS ON (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN POST-OP. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT IS GETTING BETTER FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 13057636 ↗
• InjurySep 8, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2021, THE PATIENT HAD LEFT SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF PAIN AFTER A FALL. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS NOT FULLY IN BONE ACROSS THE SI JOINT. THERE WAS A LARGE GAP IN THE SI JOINT DUE TO THE PATIENT'S DYSMORPHIC ANATOMY. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE ANTERIORLY BETWEEN THE MIDDLE AND INFERIOR POSITIONED IMPLANTS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 12439491 ↗
• InjuryJun 8, 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 REPORTED TO A NEW SURGEON WITH COMPLAINTS OF PAIN OVER THE IMPLANT SITE. THE SURGEON DETERMINED THAT THE SUPERIOR 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 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 11963098 ↗
• InjuryMay 13, 2021Malposition of Device; Malposition of Device

  PATIENT IS OSTEOPOROTIC WITH A DYSMORPHIC SACRUM AND A PREVIOUS LUMBAR FUSION. IN (B)(6) 2021, THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT HAD SI JOINT PAIN RELIEF BEFORE REPORTING LEFT SIDE RADICULAR PAIN SYMPTOMS A WEEK LATER. THE SURGEON DETERMINED THAT THE LEFT SIDE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE SUPERIOR POSITIONED IMPLANT AND INSTALLED A SHORTER IMPLANT OF THE SAME TYPE IN A NEW TRAJECTORY. 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 11816222 ↗
• InjuryMay 3, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2021, THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN CONJUNCTION WITH A LONG SPINAL CONSTRUCT PROCEDURE. ONE IMPLANT WAS INSTALLED ON EACH SIDE. THE POST-OP CT SCAN INDICATED THAT THE LEFT SIDE IMPLANT WAS MALPOSITIONED TOO VENTRALLY. THE PATIENT WAS ASYMPTOMATIC AND DID NOT REPORT ANY PAIN SYMPTOMS. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE IMPLANT. THE RIGHT SIDE IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11767275 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2021, THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED LEFT THIGH PAIN FOLLOWING THE INITIAL PROCEDURE. IMAGING AND NEUROMONITORING DID NOT SHOW THAT ANY OF THE IMPLANTS WERE MALPOSITIONED OR IMPINGING ON THE NEUROFORAMEN, BUT THE SURGEON DECIDED TO REMOVE THE SUPERIOR POSITIONED IMPLANT TO RULE IT OUT AS THE CAUSE OF THE PAIN. APPROXIMATELY TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT AND NO ADDITIONAL HARDWARE WAS ADDED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS DID NOT RESOLVE FOLLOWING THE REVISION PROCEDURE. THE SURGEON WILL RECOMMEND THAT THE PATIENT'S SPINAL CORD STIMULATOR SETTINGS BE ADJUSTED.

  Patient problems: Arthralgia

  MAUDE report 11701733 ↗
• InjuryApr 15, 2021Malposition of Device; Migration; Malposition of Device; Migration

  IN (B)(6) 2021, THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT WAS DOING WELL AFTER THE INITIAL SURGERY BEFORE COMPLAINING OF RADICULAR PAIN AFTER A FALL. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS ADVANCED INTO THE NEUROFORAMEN BECAUSE OF THE PATIENT'S FALL AND WAS NOW CAUSING RADICULAR PAIN SYMPTOMS. APPROXIMATELY THREE WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT AND NO 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 11675568 ↗
• InjuryMar 30, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2020, THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS 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) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. NO BONE GRAFT WAS PLACED IN THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11593484 ↗
• InjuryFeb 5, 2021Malposition of Device; Malposition of Device

  THE PATIENT WAS PREVIOUSLY IN A MOTOR VEHICLE ACCIDENT. IN (B)(6) 2020, THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN SYMPTOMS FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS TOO LONG AND WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN INSTALLED A SHORTER IMPLANT OF THE SAME TYPE INTO 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 11289788 ↗
• InjuryAug 4, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT REPORTED RADICULAR PAIN SYMPTOMS FOLLOWING THE INITIAL PROCEDURE. 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 AND INSTALLED A SHORTER 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 PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10362984 ↗
• InjuryJun 3, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED AN EXTEND PERIOD OF NERVE PAIN FOLLOWING THE INITIAL PROCEDURE. ALTHOUGH THE SUPERIOR POSITIONED IMPLANT LOOKED PROPERLY PLACED ON CT AND NOT IMPINGING ON THE NEUROFORAMEN, THE SURGEON DETERMINED THAT IT WAS MOST LIKELY THE PAIN GENERATOR AND DECIDED TO REMOVE IT AT THE PATIENT'S REQUEST. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT 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 10114990 ↗
• InjuryJun 2, 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'S SI JOINT PAIN RESOLVED BUT COMPLAINED OF RIGHT LEG PAIN FEW DAYS LATER. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE PULLED BACK, BUT DID NOT REMOVE, THE SUPERIOR POSITIONED IMPLANT A FEW MILLIMETERS AFTER USING CHISELS TO FREE IT FROM THE BONE. 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 10112366 ↗
• InjuryMar 30, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED LEFT LEG PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON LATER DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS MALPOSITIONED ANTERIORLY AND WAS IMPINGING ON THE NEUROFORAMEN. 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 9897905 ↗
• InjuryOct 17, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAS A DYSMORPHIC SACRUM. THE PATIENT COMPLAINED OF RADICULAR PAIN A YEAR AFTER THE PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE-POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE IMPLANT USING CHISELS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9202846 ↗
• InjuryAug 22, 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'S SI JOINT PAIN RESOLVED FOR APPROXIMATELY A WEEK BEFORE REPORTING RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT HAD ENCROACHED ON THE S1 NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED UP THE SUPERIOR POSITIONED IMPLANT A FEW MILLIMETERS. THE IMPLANT WAS NOT REMOVED. THE SURGEON BELIEVES THAT THE PATIENT'S RADICULAR PAIN SYMPTOMS WILL RESOLVE FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8921029 ↗
• InjuryAug 12, 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 RIGHT LEG RADICULAR PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT HAD BREACHED THE S1 NEUROFORAMEN CAUSING RADICULAR PAIN. FOUR WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE BACKED UP THE SUPERIOR POSITIONED IMPLANT A FEW MILLIMETERS. THE IMPLANT WAS NOT REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8884635 ↗
• InjuryJul 19, 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 SI JOINT PAIN RELIEF BEFORE REPORTING FOOT DROP WITHOUT PAIN THREE DAYS AFTER THE INITIAL PROCEDURE. 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. 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 8809657 ↗
• InjuryJul 3, 2019Malposition of Device; Malposition of Device

  THE OBESE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT COMPLAINED OF LEFT SIDE RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE 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 8760992 ↗
• InjuryJun 26, 2019Adverse 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) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER REPORTED ONGOING SI JOINT PAIN. THE SURGEON BELIEVED THE SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. THE IMPLANT WAS DIFFICULT TO REMOVE AS IT WAS SOLIDLY FIXED IN BONE AND WAS NOT LOOSE. THE SURGEON DID NOT INDICATE THAT THE IMPLANT WAS MALPOSITIONED. HE THEN REPLACED IT WITH A LARGER IMPLANT OF THE SAME TYPE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8735718 ↗
• InjuryMay 17, 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 HAS POOR BONE QUALITY AND IMAGING WAS DIFFICULT. THE PATIENT COMPLAINED OF INABILITY TO MOVE HER LEFT LEG POST-OP. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. A FEW HOURS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND INSTALLED A NEW, SHORTER, IMPLANT OF THE SAME TYPE IN AN INFERIOR POSITION TO THE REMAINING IMPLANTS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR SYMPTOMS, INABILITY TO MOVE HER LEFT LEG, RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8621511 ↗
• InjuryApr 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 IMPLANT WAS IRRITATING THE NERVE ROOT. 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 8565459 ↗
• InjuryFeb 28, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED VIA CT SCAN THAT WHILE THE MOST SUPERIOR POSITIONED IMPLANT HAD NOT BREACHED THE NEUROFORAMEN, A BONE FRAGMENT WAS INSIDE THE NEUROFORAMEN IMPINGING ON THE NERVE ROOT. IN (B)(6) 2018, THE SURGEON PERFORMED A MINIMALLY INVASIVE HEMI-FORAMINOTOMY TO REMOVE THE BONE FRAGMENT WHICH WAS SUCCESSFUL; HOWEVER, THE PATIENT STILL HAD RADICULOPATHY SYMPTOMS POST-OP. THE SURGEON DECIDED TO REMOVE THE SUPERIOR POSITIONED IMPLANT. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE THE SUPERIOR POSITIONED IMPLANT WAS REMOVED AND REPLACED IT WITH A SHORTER AND WIDER 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: Bone Fracture(s); Undesired Nerve Stimulation

  MAUDE report 8379887 ↗
• InjuryFeb 28, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR FOOT PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE IMPLANT AND REPLACED IT WITH A SHORTER AND WIDER 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 8379823 ↗
• InjuryJan 31, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT REPORTED RADICULAR PAIN SYMPTOMS FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS INSTALLED IN A "TOO" SUPERIOR POSITION RESULTING IN NERVE IMPINGEMENT. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND ADDED A NEW IMPLANT OF THE SAME TYPE IN A DIFFERENT POSITION. THE PATIENT IS DOING BETTER FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8294630 ↗