iFuse Implant System 7055M-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00851085007503), received between Feb 7, 2019 and Dec 29, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Malposition of Device” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAS ANOMALOUS PELVIS ANATOMY. THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS ON (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED PSEUDARTHROSIS OF THE JOINT WITH AN ANOMALOUS ALA. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT. NO NEW HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia; Undesired Nerve Stimulation

  MAUDE report 13112754 ↗
• InjuryApr 20, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2021 THE PATIENT HAD RIGHT BILATERAL SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT REPORTED LEFT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE LEFT SIDE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT AND NO ADDITIONAL 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 11697469 ↗
• InjuryJan 13, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAS A PREEXISTING RIGHT SIDE SI JOINT/SPINAL CONSTRUCT. IN (B)(6) 2020 THE SURGEON PERFORMED A RIGHT SIDE SI JOINT ARTHRODESIS ON THE PATIENT WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED RIGHT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS MALPOSITIONED AND TOUCHING A PREEXISTING ILIOSACRAL SCREW CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT USING CHISELS AND REPLACED IT WITH A SHORTER, AND WIDER, IMPLANT OF THE SAME TYPE USING THE EXPLANT VOID. THE PREEXISTING MIDDLE AND CAUDAL POSITIONED IMPLANTS WERE NOT ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11165033 ↗
• InjuryNov 17, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED LEFT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND FILLED THE EXPLANT VOID WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENTS PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10854516 ↗
• InjuryOct 20, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD A RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF PAIN AROUND THE SURGICAL SITE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM CAUSING PAIN AROUND THE SURROUNDING TISSUES. IN (B)(6) 2020, THE SURGEON REMOVED THE CRANIAL POSITIONED IMPLANT USING CHISELS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENTS PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 10708658 ↗
• InjuryFeb 27, 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 COMPLAINED OF RIGHT SIDE RADICULAR PAIN AFTER A SHORT PERIOD OF PAIN RELIEF. 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 REMOVED THE IMPLANT. IT TOOK CONSIDERABLE EFFORT TO REMOVE THE IMPLANT AS IT WAS SOLIDLY FIXED IN BONE. 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 9763671 ↗
• InjuryFeb 13, 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 COMPLAINED OF RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD SLIGHTLY BREACHED THE NEUROFORAMEN. NINE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED UP THE SUPERIOR POSITIONED IMPLANT A FEW MILLIMETERS BUT DID NOT REMOVE IT. 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 9706166 ↗
• 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 COMPLAINED OF RIGHT SIDE RADICULAR PAIN FOLLOWING THE 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 IMPLANT USING CHISELS DUE TO THE IMPLANT BEING SOLIDLY FIXED IN BONE. 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 RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9376822 ↗
• InjuryOct 24, 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 HAD SI JOINT PAIN RELIEF BUT LATER COMPANIED OF LEFT SIDE RADICULAR PAIN. 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 IMPLANT USING CHISELS DUE TO THE IMPLANT BEING SOLIDLY FIXED IN BONE. 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 9234452 ↗
• InjuryMay 29, 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 DID WELL FOR A MONTH FOLLOWING THE INITIAL PROCEDURE BEFORE COMPLAINING OF LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED LEFT SIDE IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. 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 8652236 ↗
• InjuryFeb 7, 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 LATER COMPLAINED OF RADICULAR PAIN. THE SURGEON DETERMINED VIA CT SCANS THAT THE MOST CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE. AN ADDITIONAL IMPLANT OF THE SAME TYPE WAS ADDED IN A MORE CAUSAL POSITION TO HELP FIXATE THE SI 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 8315615 ↗