iFuse Implant System 7080M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851085007558), received between Feb 24, 2020 and Jun 2, 2021 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD TRAUMA FROM A MOTOR VEHICLE ACCIDENT. IN (B)(6) 2020, THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS DURING A TRAUMA PROCEDURE WHERE ONE IMPLANT WAS INSTALLED ACROSS THE SI JOINT. THE PATIENT LATER COMPLAINED ABOUT LOW BACK PAIN. THE SURGEON DID NOT INDICATE THAT THE IMPLANT WAS MALPOSITIONED OR LOOSE. THERE WAS NO NERVE IMPINGEMENT. THE SURGEON DECIDED THAT THE BEST COURSE OF ACTION WAS TO REMOVE THE IMPLANT AT THE PATIENT'S REQUEST. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT USING CHISELS AS THE IMPLANT WAS SOLIDLY FIXED IN BONE. NO BONE GRAFT OR NEW HARDWARE WAS ADDED TO THE SI JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11925897 ↗
• InjuryJan 13, 2021Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD RIGHT SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE ONE IMPLANT WAS INSTALLED 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 RIGHT 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 RIGHT SIDE SI JOINT IMPLANT AND FILLED THE EXPLANT VOID WITH BONE GRAFT. HE THEN ADDED TWO ADDITIONAL IMPLANTS OF THE SAME TYPE TO THE RIGHT SI JOINT TO HELP FIXATE THE SI JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11165000 ↗
• InjuryOct 8, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN SEPTEMBER WHERE ONE IMPLANT WAS IN INSTALLED ON EACH SIDE IN CONJUNCTION WITH A LONG DEFORMITY FUSION. THE PATIENT REPORTED LEFT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DECIDED TO REMOVE THE LEFT SIDE IMPLANT WHILE HE WAS REVISING A SET SCREW IN CASE THE IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. THREE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE ALSO ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE TO THE RIGHT SIDE. THE INITIAL RIGHT SIDE IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10653409 ↗
• DeathFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ELDERLY PATIENT UNDERWENT A LENGTHY SPINAL DEFORMITY SURGERY INCLUDING THE BILATERAL INSTALLATION OF TWO SI JOINT IMPLANTS. THE PATIENT SUFFERED EXTENSIVE BLOOD LOSS DURING THE PROCEDURE. THE PATIENT CODED ON THE TABLE AT THE END OF THE CASE, WAS RESUSCITATED THEN CODED AGAIN WITHOUT RESUSCITATION. MEDICAL OPINION OF CHIEF MEDICAL OFFICER: "THE SI JOINT IMPLANTS AND THE PORTION OF THE OVERALL SURGICAL PROCEDURE TO PLACE THE SI JOINT IMPLANTS ARE NOT RELATED TO PATIENT MORTALITY. THE BLEEDING IN THIS CASE (THE PRIMARY CAUSATIVE FACTOR) WAS A RESULT OF THE SPINAL DEFORMITY SURGERY, INCLUDING THE SPINAL OSTEOTOMIES. THERE IS NOT TYPICALLY A SIGNIFICANT AMOUNT OF BLEEDING ASSOCIATED WITH PLACEMENT OF S2AI SCREWS WITH OR WITHOUT THE CONCOMITANT PLACEMENT OF SI JOINT IMPLANTS. THERE WAS NO SIGNIFICANT BLEEDING REPORTED IN THIS CASE THAT WAS DIRECTLY RELATED TO THE PLACEMENT OF THE SI JOINT IMPLANTS. WHEN SI JOINT IMPLANTS ARE PLACED IN CONJUNCTION WITH S2AI SCREWS, IT TYPICALLY TAKES AN ADDITIONAL 10 MINUTES PER IMPLANT. THIS ADDITIONAL TIME IS NOMINAL COMPARED TO THE MANY HOURS TAKEN TO PERFORM THE SPINAL DEFORMITY SURGERY. IT IS NOTED THAT THE SURGEON DID REVISE THE POSITION OF THE

  Patient problems: Blood Loss; Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9745009 ↗