iFuse Implant System 7070-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00859256003347), received between Nov 17, 2015 and Apr 2, 2019 — classified as 12 injuries.

The most frequently reported specific device problem is “Malposition of Device” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE S1 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 8473541 ↗
• InjuryAug 24, 2017Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT IS OBESE AND HAS A DYSMORPHIC SACRUM WHICH MADE PREOPERATIVE IMAGING CHALLENGING. THE PATIENT'S SI JOINT PAIN DECREASED AFTER THE INITIAL PROCEDURE, BUT THE PATIENT COMPLAINED OF NEW RIGHT FOOT PAIN THAT BECAME WORSE OVER THE NEXT FEW DAYS. THE SURGEON DETERMINED THAT THE MOST SUPERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR FOOT PAIN IMPROVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Numbness; Undesired Nerve Stimulation

  MAUDE report 6818199 ↗
• InjuryJan 17, 2017Malposition of Device; Malposition of Device

  THE PATIENT INITIALLY HAD SI JOINT PAIN RELIEF FOLLOWING SI JOINT ARTHRODESIS IN (B)(6) 2016. TWO WEEKS POST-OP, THE PATIENT PRESENTED WITH RADICULAR LEG PAIN COMPLAINTS. THE SURGEON DETERMINED THAT THE MOST CEPHALAD IMPLANT HAD BREACHED THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CEPHALAD IMPLANT AND REPLACED IT WITH A SHORTER AND WIDER IMPLANT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION SURGERY.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 6256182 ↗
• InjuryDec 15, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT REPORTED RADICULAR PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED THAT THE MOST CRANIAL IMPLANT HAD BREACHED THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. A WEEK AFTER THE INITIAL SURGERY, THE SURGEON PERFORMED A REVISION SURGERY WHERE THE CRANIAL IMPLANT WAS REMOVED AND REPLACED WITH A SHORTER IMPLANT IN ORDER TO ALLEVIATE THE NERVE IMPINGEMENT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 6176940 ↗
• InjuryNov 28, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT REPORTED RADICULAR PAIN FOLLOWING THE SURGERY. THE SURGEON DETERMINED THAT THE MOST CRANIAL IMPLANT HAD BREACHED THE NEUROFORAMEN AND WAS IRRITATING THE NERVE ROOT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE THE CRANIAL IMPLANT WAS REMOVED AND REPLACED WITH A SHORTER IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 6130274 ↗
• InjuryMar 23, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF LEG PAIN FOLLOWING THE SURGERY. CT SCANS LATER REVEALED THAT THE SUPERIOR IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPINGING IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT IN A DIFFERENT POSITION. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION SURGERY AND WAS "DOING WELL."

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 5520014 ↗
• InjuryJan 25, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT'S SI JOINT PAIN IMPROVED FOLLOWING THE PROCEDURE BUT COMPLAINED OF NEW LEG PAIN. CT SCANS SHOWED THAT THE SUPERIOR IMPLANT WAS TOO LONG AND HAD BREACHED THE S1 NEUROFORAMEN. A WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT AND REPLACED IT WITH A SHORTER ONE USING THE SAME HOLE. NO OTHER IMPLANTS WERE REMOVED OR ADJUSTED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 5389739 ↗
• InjuryJan 15, 2016Malposition of Device; Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR LEG PAIN FOLLOWING THE PROCEDURE. THE SURGEON THOUGHT THAT THE MOST SUPERIOR IMPLANT MIGHT BE IMPINGING ON THE S1 NEUROFORAMEN, CAUSING RADICULAR PAIN. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT AND THEN ADDED A SHORTER IMPLANT IN A MORE SUPERIOR POSITION. THE EXPLANT HOLE WAS NOT FILLED WITH BONE GRAFT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 5369904 ↗
• InjuryDec 2, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT'S SI JOINT PAIN WAS RESOLVED AFTER THE INITIAL SURGERY BUT HE LATER COMPLAINED OF NEW MINOR FOOT PAIN. CT SCANS REVEALED THAT THE SUPERIOR IMPLANT WAS IMPINGING ON THE S1 NEUROFORAMEN. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT THAT WAS IMPINGING ON THE NEUROFORAMEN AND REPLACED IT WITH A SHORTER IMPLANT IN THE SAME HOLE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT YET KNOWN.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 5261287 ↗
• InjuryNov 17, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR LEG PAIN IMMEDIATELY FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST SUPERIOR IMPLANT WAS IMPINGING ON THE L5 NERVE ROOT. A FEW DAYS FOLLOWING THE INITIAL SURGERY, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT THAT WAS IMPINGING ON THE L5 NERVE ROOT AND REPLACED IT WITH A SHORTER IMPLANT IN THE SAME HOLE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 5229935 ↗
• InjuryNov 17, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR LEG PAIN IMMEDIATELY FOLLOWING THE PROCEDURE. THE SURGEON STATED THAT THE PATIENT HAD A "SMALLER, MORE DIFFICULT ANATOMY," AND THAT THE MOST SUPERIOR IMPLANT WAS IMPINGING ON THE S1 NEUROFORAMEN. A FEW WEEKS LATER IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT THAT WAS IMPINGING ON THE NEUROFORAMEN AND REPLACED IT WITH A SHORTER IMPLANT IN THE SAME HOLE. THE PATIENT'S RADICULAR LEG PAIN RESOLVED COMPLETELY FOLLOWING THE REVISION SURGERY.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 5229894 ↗
• InjuryNov 17, 2015Malposition of Device

  IN (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR LEG PAIN IMMEDIATELY FOLLOWING THE PROCEDURE. THE SURGEON STATED THAT THE PATIENT HAD A "SMALLER, MORE DIFFICULT ANATOMY," AND THAT THE MOST SUPERIOR IMPLANT WAS IMPINGING ON THE S1 NEUROFORAMEN. THE DAY AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SUPERIOR IMPLANT THAT WAS IMPINGING ON THE NEUROFORAMEN AND REPLACED IT WITH A SHORTER IMPLANT IN THE SAME HOLE. THE PATIENT'S RADICULAR LEG PAIN RESOLVED COMPLETELY FOLLOWING THE REVISION SURGERY.

  Patient problems: Nerve Proximity Nos (Not Otherwise Specified); Pain; Undesired Nerve Stimulation

  MAUDE report 5229889 ↗