iFuse Implant System 7075M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00851085007527), received between Jan 23, 2021 and Jan 6, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Malposition of Device” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2022Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN DEC 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN POST-SURGERY DURING RECOVERY. THE SUPERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. NEXT DAY, 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 STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 13173921 ↗
• InjuryJun 17, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2021, THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS WHERE ONE IMPLANT WAS INSTALLED ON EACH SIDE. THE PATIENT REPORTED CONTINUED LEFT SIDE SI JOINT PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE LEFT SIDE IMPLANT WAS MALPOSITIONED AND NOT FULLY ACROSS THE SI JOINT. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE IMPLANT AND INSTALLED A NEW IMPLANT OF THE SAME TYPE AND LENGTH IN A MORE POSTERIOR APPROACH. HE THEN INSTALLED AN ADDITIONAL IMPLANT IN THE LEFT SI JOINT TO HELP STABILIZE THE JOINT. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 12018066 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE ONE IMPLANT WAS INSTALLED. THE PATIENT LATER COMPLAINED OF RIGHT SIDE SI JOINT PAIN AND REQUESTED THAT THE IMPLANT BE REMOVED. THE SURGEON SAID THERE WAS NO MEDICAL REASON TO REMOVE THE IMPLANT BUT AGREED TO REMOVE IT AT THE PATIENT'S REQUEST. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. IT IS NOT KNOWN IF THE SURGEON FILLED THE EXPLANT VOID WITH BONE GRAFT. THERE WAS GOOD BONY GROWTH BOTH ON THE INSIDE AND THE OUTSIDE OF THE REMOVED IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11621627 ↗
• InjuryMar 10, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE ONE IMPLANT WAS INSTALLED. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND REPLACED IT WITH A NEW IMPLANT OF THE SAME SIZE AND TYPE IN A NEW POSITION. THERE WERE NO REPORTED PATIENT COMPLAINTS. THE SURGEON DID NOT OFFER A REASON AS TO WHY HE REPLACED THE LEFT SIDE IMPLANT, BUT IT WAS LIKELY DUE TO SUBOPTIMAL INITIAL POSITIONING. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11454931 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO PROBLEM WITH THE SI JOINT IMPLANTS OR THE PLACEMENT OF THE SI JOINT IMPLANTS. THE PATIENT HAD BILATERAL SI JOINT FUSION IN CONJUNCTION WITH A SPINAL LONG CONSTRUCT IN (B)(6) 2019. THE PATIENT LATER DEVELOPED AN INFECTION AT THE SURGERY SITE. THE PATIENT HAS A PREVIOUS HISTORY OF INFECTIONS. THE SURGEON DETERMINED THAT THE SPINAL SCREWS WERE LOOSE, BUT THAT THE SI JOINT IMPLANTS WERE SOLID. IN (B)(6) 2021, THE SURGEON DECIDED TO REMOVE THE SPINAL HARDWARE AND SI JOINT IMPLANTS. THE SURGEON DID NOT THINK THAT THE INFECTION WAS RELATED TO THE SI JOINT IMPLANTS. IN (B)(6) 2021, THE SURGEON REMOVED THE LEFT AND RIGHT SIDE SPINAL SCREWS AND RODS. HE ALSO REMOVED THE RIGHT SIDE SI JOINT IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. THE LEFT SIDE SI JOINT IMPLANT WAS SOLIDLY FIXED IN BONE AND WAS LEFT IN PLACE. THE SURGEON CLOSED THE WOUND WITH SUTURES USING ANTIBIOTIC BALLS. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE AND HAS BEEN RELEASED TO GO HOME.

  Patient problems: Cellulitis

  MAUDE report 11395820 ↗
• InjuryJan 28, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE METAL IMPLANTS AND ONE BONE IMPLANT WERE INSTALLED. THE PATIENT REPORTED RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED METAL IMPLANT WAS PUSHED FORWARD INTO THE NEUROFORAMEN DURING THE INSTALLATION OF THE BONE IMPLANT CAUSING RADICULAR PAIN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON BACKED-UP, BUT DID NOT REMOVE, THE MIDDLE POSITIONED IMPLANT APPROXIMATELY 15 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 11248553 ↗
• InjuryJan 23, 2021Malposition of Device; Malposition of Device

  THE PATIENT WAS PREVIOUSLY IN A MOTOR VEHICLE ACCIDENT AND HAD SCREWS PLACED IN HER LEFT SI JOINT. IN (B)(6) 2020, THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS WHERE ONE OF THE PREEXISTING ILIOSACRAL SCREWS WAS REMOVED AND REPLACED WITH A NEW IMPLANT. AN ADDITIONAL IMPLANT WAS ALSO INSTALLED IN THE SI JOINT. THE PATIENT COMPLAINED OF RADICULAR PAIN SYMPTOMS FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS TOO LONG AND HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE SHE REMOVED THE SUPERIOR POSITIONED IMPLANT. SHE 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 11219853 ↗