iFuse Implant System 7050M-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851085007497), received between Feb 19, 2019 and Nov 11, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 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 REPORTED RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. THE DAY 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 USING 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 12800276 ↗
• InjuryAug 3, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD SI JOINT ARTHRODESIS AROUND (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED SI JOINT PAIN SYMPTOMS FOLLOWING THE PROCEDURE. THE SURGEON LATER DETERMINED THAT THE CAUDAL POSITIONED IMPLANT MAY HAVE BEEN LOOSE DUE TO A MICROFRACTURE IN THE BONE AROUND THE IMPLANT. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT USING CHISEL AND FILLED THE EXPLANT VOID WITH BONE GRAFT. NO OTHER MEDICAL PROCEDURE WAS PERFORMED TO TREAT THE MICROFRACTURE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia; Bone Fracture(s)

  MAUDE report 10360251 ↗
• InjuryApr 8, 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 COMPLAINED OF LEFT SIDE RADICULAR PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO OTHER HARDWARE OR BONE GRAFT WAS ADDED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9938365 ↗
• InjuryMar 3, 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 COMPLAINED OF RIGHT SIDE RADICULAR LEG PAIN A WEEK AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE 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 9780430 ↗
• InjuryFeb 19, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE BUT LATER REPORTED PAIN COMPLAINTS AFTER A FALL. THE SURGEON DETERMINED THAT THE FALL LIKELY CAUSED A SACRAL FRACTURE AROUND THE MOST CAUDAL POSITIONED IMPLANT CAUSING IT TO BECOME LOOSE. ALL THE IMPLANTS WERE WELL POSITIONED AND NOT LOOSE BEFORE THE FALL. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CAUDAL IMPLANT. THIS IS A LOW SEVERITY AND LOW OCCURRENCE EVENT. THE STATUS OF THE PATIENT FOLLOWING THE PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia; Bone Fracture(s)

  MAUDE report 8352060 ↗