iFuse Implant System 7070M-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00851085007459), received between Oct 9, 2018 and Jul 13, 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.

• InjuryJul 13, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT HAS A DYSMORPHIC SACRUM WITH L5 SACRALIZATION. THE PATIENT REPORTED LEFT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. 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 SURGERY WHERE HE BACKED-UP, BUT DID NOT REMOVE, THE SUPERIOR POSITIONED IMPLANT APPROXIMATELY 5-10 MILLIMETERS TO RELIEVE THE NERVE IMPINGEMENT. HE THEN INSTALLED AN ADDITIONAL IMPLANT OF THE SAME TYPE INFERIOR TO THE EXISTING IMPLANTS TO HELP FIXATE THE SI JOINT 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 12159433 ↗
• InjuryMar 5, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD A PREVIOUS AUTOMOBILE TRAUMA PELVIC INJURY TREATED WITH PUBIC SYMPHYSIS PLATING AND ILIOSACRAL SCREW FIXATION. THE PATIENT HAD A COLLAPSED STRUCTURE OF THE SACRAL ALA BECAUSE OF THE ORIGINAL INJURY. IN (B)(6) 2021, THE SURGEON PERFORMED A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT WHERE THREE IMPLANTS WERE INSTALLED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND NO IMMEDIATE POST-OPERATIVE COMPLICATIONS. THE PATIENT LATER REPORTED WEAKNESS OF THE LEFT ANKLE DORSI AND PLANTAR FLEXION. THE SURGEON DETERMINED DISPLACEMENT OF THE L5 NERVE ROOT SO THAT IT WAS POSITIONED IN AN ADHERENT LOCATION IN THE VICINITY OF THE SUPERIOR POSITIONED IMPLANT. THE ALTERED ANATOMY OF THE SACRAL ALA BECAUSE OF THE TRAUMATIC PELVIC RING FRACTURE SIGNIFICANTLY CONTRIBUTED TO THE L5 NERVE IRRITATION/INJURY. THE ALTERED PELVIC ANATOMY MAY HAVE MADE IMAGING DIFFICULT DURING THE IMPLANT INSTALLATION PROCEDURE. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT AND NO ADDITIONAL HARDWARE WAS ADDED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT WAS DOING WELL FOLLOW

  Patient problems: Bone Fracture(s); Undesired Nerve Stimulation

  MAUDE report 11424265 ↗
• InjuryNov 17, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAS A DYSMORPHIC SACRUM. THE PATIENT HAD A RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED RIGHT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT WAS TOO LONG AND HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S SI JOINT AND RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10854820 ↗
• InjuryNov 13, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD A RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED RIGHT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON ATTEMPTED TO REMOVE THE CRANIAL IMPLANT, BUT HE WAS UNABLE TO REMOVE THE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. THE SURGEON IS CONSIDERING PERFORMING AN S1 NERVE ROOT DECOMPRESSION AT A LATER DATE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENTS RADICULAR PAIN SYMPTOMS HAVE NOT RESOLVED. UPDATED: IN (B)(6) 2020, A DIFFERENT SURGEON WAS ABLE TO SUCCESSFULLY REMOVE THE CRANIAL IMPLANT USING THE CHISELS. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT OR OTHER HARDWARE. 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 10840735 ↗
• InjurySep 2, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT'S SI JOINT PAIN SYMPTOMS RESOLVED BUT SHE COMPLAINED OF RIGHT LEG NUMBNESS FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE RIGHT SIDE CRANIAL IMPLANT HAD PUSHED BONE FRAGMENTS INTO THE S1 NEUROFORAMEN, CAUSING THE LEG NUMBNESS. FIVE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND INSTALLED A SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S LEG NUMBNESS SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10485949 ↗
• InjuryAug 19, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE. THE PATIENT COMPLAINED OF RIGHT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE RIGHT SIDE CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. THREE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE CRANIAL POSITIONED IMPLANT. HE THEN INSTALLED A NEW, SHORTER, IMPLANT OF THE SAME TYPE IN A DIFFERENT POSITION. 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 10426677 ↗
• InjuryNov 7, 2019Malposition of Device; Malposition of Device

  IN (B)(6) 2019, THE SURGEON PERFORMED A LEFT SIDE PELVIC FRACTURE TRAUMA PROCEDURE WHERE HE USED ONE IMPLANT TO HELP FIXATE THE SI JOINT. THE PATIENT COMPLAINED OF LEFT SIDE RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE IMPLANT HAD BREACHED THE NEUROFORAMEN. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9290638 ↗
• InjurySep 23, 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 RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. FIVE 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 RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9105775 ↗
• InjuryJul 9, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR PAIN TWO DAYS FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED LEFT SIDE IMPLANT WAS IMPINGING ON THE NERVE ROOT. ONE WEEK 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 RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8771345 ↗
• InjuryFeb 28, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD PAIN RELIEF FOR SIX MONTHS BEFORE COMPLAINING OF RADICULAR PAIN AFTER A FALL. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN AFTER THE FALL. 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. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Fall; Undesired Nerve Stimulation

  MAUDE report 8379866 ↗
• InjuryOct 9, 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 PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED IMPLANT WAS TOO LONG AND WAS IMPINGING ON THE NEUROFORAMEN. FOUR DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE IN A NEW POSITION. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7949513 ↗