iFuse Implant System 7065M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00851085007442), received between Dec 5, 2017 and Dec 21, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Malposition of Device” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 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 DID WELL FOR THREE WEEKS BEFORE REPORTING TO A DIFFERENT SURGEON WITH COMPLAINTS OF RADICULAR PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS AS THE IMPLANT WAS SOLIDLY FIXED IN BONE. NO BONE GRAFT OR ADDITIONAL 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: Undesired Nerve Stimulation

  MAUDE report 13055387 ↗
• InjuryMar 19, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2021, 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 HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED AND INSTALLED A 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 11531885 ↗
• InjuryJan 13, 2021Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE ONE IMPLANT WAS INSTALLED ON EACH SIDE IN CONJUNCTION WITH A LONG SPINAL FUSION CONSTRUCT. THE PATIENT LATER COMPLAINED OR A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED LUCENCY AROUND THE DISTAL TIP OF THE LEFT SIDE SI JOINT IMPLANT AND THAT IT MAY NOT HAVE BEEN FULLY FUSED IN BONE. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE SI JOINT IMPLANT USING CHISELS. THE EXPLANT VOID WAS FILLED WITH BONE GRAFT. THE PREEXISTING RIGHT SIDE SI JOINT IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11164920 ↗
• InjuryNov 13, 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 LATER COMPLAINED OF RADICULAR. THE SURGEON DETERMINED THAT THE MOST 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 MOST CRANIAL POSITIONED IMPLANT WITH 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 10840753 ↗
• InjuryJun 17, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT REPORTED LEFT LEG RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE LEFT SIDE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE SUPERIOR POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A SHORTER IMPLANT OF THE SAME TYPE 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: Undesired Nerve Stimulation

  MAUDE report 10164125 ↗
• InjuryNov 4, 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. SIX DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS IMPROVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9272329 ↗
• InjuryFeb 26, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN TWO WEEKS AFTER 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 AND REPLACED IT WITH A SHORTER AND WIDER 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 8371171 ↗
• InjuryNov 29, 2018Malposition of Device; Malposition of Device

  IN (B)(6) 2018, THE PATIENT UNDERWENT AN INITIAL LEFT SIDE SI JOINT ARTHRODESIS. DURING THE INSTALLATION OF THE FIRST IMPLANT, THE SURGEON EXPERIENCED DIFFICULTIES WITH PIN ADVANCEMENT AND MALPOSITIONING OF THE IMPLANT. THE IMPLANT BREACHED THE ANTERIOR CORTEX. THE SURGEON WAS UNABLE TO REMOVE THE IMPLANT, SO HE TRANSFERRED THE PATIENT TO A TRAUMA SURGEON WHO REMOVED THE IMPLANT LATER THAT SAME DAY. THERE WERE NO VASCULAR COMPLICATIONS OR NEUROLOGICAL DAMAGE. THE PATIENT WAS STABLE IN RECOVERY FOLLOWING THE IMPLANT REMOVAL.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8115227 ↗
• InjurySep 10, 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 COMPLAINED OF RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT MAY HAVE PUSHED BONE INTO THE NEUROFORAMEN. THE DAY AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. 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 7861058 ↗
• InjuryDec 5, 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 PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED LEFT SIDE IMPLANT HAD BREACHED THE NEUROFORAMEN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON REMOVED THE CRANIAL POSITIONED IMPLANT AND INSTALLED A SHORTER IFUSE IMPLANT IN NEW POSITION. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7082838 ↗