iFuse Implant System 7065M-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00851085007510), received between May 17, 2019 and Sep 15, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Malposition of Device” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT LATER COMPLAINED OF RIGHT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE RIGHT SIDE CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE RIGHT SIDE CRANIAL POSITIONED IMPLANT USING CHISELS. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT OR NEW HARDWARE. 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 12478659 ↗
• InjuryApr 7, 2021Malposition of Device; Malposition of Device

  IN (B)(6) THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT INITIALLY DID WELL AFTER THE PROCEDURE BUT LATER REPORTED LEFT SIDE RADICULAR FOOT PAIN. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS MALPOSITIONED AND HAD BREACHED THE S1 NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT USING CHISELS. THERE WAS GOOD BONE GROWTH ON THE EXPLANTED IMPLANT. HE THEN REPLACED IT WITH A SHORTER 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 11631386 ↗
• InjuryNov 17, 2020Malposition of Device; Malposition of Device

  PREVIOUS REVISION: IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE. UPDATED: PATIENT REPORTED TO THE SAME A NEW SURGEON WITH A RECURRENCE OF RADICULAR PAIN SYMPTOMS. THE SURGEON REMOVED THE MIDDLE IMPLANT WITH 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 PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE ADDITIONAL REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10856227 ↗
• InjuryNov 17, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD A LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR FOUR MONTHS AFTER THE INITIAL PROCEDURE BEFORE REPORTING LEFT SIDE RADICULAR PAIN. 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 USING CHISELS. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT OR NEW HARDWARE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS HAVE PARTIALLY RESOLVED ONE WEEK AFTER THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10855390 ↗
• InjuryJan 2, 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 RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THERE WAS A BONE FRAGMENT CAUSED BY THE INSTALLATION OF THE SUPERIOR POSITIONED IMPLANT THAT MAY HAVE BEEN COMPRESSING THE NERVE IN THE NEUROFORAMEN IN THE S1 POSITION. IN (B)(6) 2019, A DIFFERENT SURGEON REMOVED THE SUPERIOR POSITIONED IMPLANT AND PLACED BONE GRAFT IN THE EXPLANT VOID. 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 9539251 ↗
• InjuryMay 17, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE TWO IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED LEFT SIDE IMPLANT WAS IMPINGING ON THE S1 NERVE ROOT. EIGHT DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED UP, BUT DID NOT REMOVE, THE SUPERIOR POSITIONED LEFT SIDE IMPLANT APPROXIMATELY FIVE MILLIMETERS. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8621471 ↗