iFuse Implant System 7070M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00851085007541), received between Nov 21, 2017 and Aug 31, 2023 — classified as 19 injuries.

The most frequently reported specific device problem is “Malposition of Device” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2023, SI-BONE LEARNED OF AN ILIUM FRACTURE CASE THAT HAD OCCURRED IN LATE 2021. THE PATIENT HAD MULTILEVEL SPINE FUSION SURGERY WITH PLACEMENT OF BOTH PELVIC FIXATION SCREWS AND IFUSE IN THE SAI CONFIGURATION ON (B)(6) 2021. ABOUT 2 WEEKS POST-OP, THE PATIENT HEARD A POP. CT SCAN SHOWS A LARGE, DISPLACED ILIUM FRACTURE. THE SURGEON INSTALLED SCREWS A FEW MONTH LATER TO HELP FIXATE THE ILIUM FRACTURE. IT IS UNKNOWN WHETHER THE IFUSE IMPLANTS WERE CAUSALLY RELATED, BUT IT WAS THE IMPLANT THAT WAS CLOSEST TO THE FRACTURE LOCATION AND PATIENT MOVEMENT CAN IMPOSE A LARGE LEVER FORCE ON THE PELVIC BONES. BONE FRACTURE IS A KNOWN RISK OF PLACEMENT OF METALLIC DEVICES INTO PELVIC BONE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17666938 ↗
• InjuryOct 28, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD A PREVIOUS LUMBAR FUSION. IN (B)(6) 2021, THE SURGEON PERFORMED A RIGHT SIDE SI JOINT ARTHRODESIS ON THE PATIENT INSTALLING ONE IMPLANT WHILE REVISING A LUMBAR CONSTRUCT. THE PATIENT REPORTED RADICULAR PAIN TWO WEEKS AFTER THE PROCEDURE. THE SURGEON DETERMINED THAT THERE WAS A SMALL, COMMINUTED FRACTURE JUST SUPERIOR TO THE SCIATIC NOTCH AREA AT THE TOP OF THE IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND INSTALLED AN ILIAC BOLT SUPERIOR TO THE EXPLANT VOID. NO BONE GRAFT WAS PLACED IN THE EXPLANT VOID AND NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENTS RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

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

  MAUDE report 12716307 ↗
• InjuryAug 6, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE ONE IMPLANT WAS INSTALLED ON EACH SIDE IN CONJUNCTION WITH A LONG SPINAL CONSTRUCT. THE PATIENT LATER COMPLAINED OF LEFT SIDE FOOT DROP. THE SURGEON DETERMINED THAT THE LEFT SIDE IMPLANT WAS MALPOSITIONED AND DECIDED TO REMOVE IT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. THE PREEXISTING CONTRALATERAL, RIGHT SIDE, IMPLANT WAS LEFT IN PLACE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12288493 ↗
• InjuryMay 13, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD A FEW DAYS OF SI JOINT PAIN RELIEF FOLLOWING THE INITIAL SURGERY BUT LATER REPORTED RADICULAR LEG PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS TOO LONG AND WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. NINE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND INSTALLED A SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. 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 11823525 ↗
• InjuryMar 10, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2020, THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN SYMPTOMS FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE 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 11454970 ↗
• InjuryAug 13, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED OCCASIONAL RIGHT SIDE RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED TWO NEW, SHORTER, IMPLANTS OF THE SAME TYPE IN MORE ANTERIOR POSITIONS. 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 10402637 ↗
• InjuryAug 4, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT'S SI JOINT PAIN RESOLVED, BUT SHE LATER REPORTED MINOR LEG PAIN. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND INSTALLED A SHORTER IMPLANT OF THE SAME TYPE IN A MORE POSTERIOR 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 10365632 ↗
• InjuryAug 4, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND INSTALLED A SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. 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 10365613 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE SECTION H.10.

  Patient problems: Bacterial Infection; Hematoma

  MAUDE report 10197513 ↗
• InjuryMay 11, 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 LATER COMPLAINED OF RIGHT CALF AND FOOT NUMBNESS AND TINGLING. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE L5 NERVE ROOT. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE. BONE GRAFT WAS ADDED TO THE EXPLANT VOID. 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 10043814 ↗
• InjuryMar 3, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT COMPLAINED OF LEFT SIDE RADICULAR PAIN THE DAY AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE LEFT SIDE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED LEFT SIDE SUPERIOR POSITIONED IMPLANT. HE THEN INSTALLED A NEW, SHORTER IMPLANT OF THE SAME TYPE IN A MORE CAUDAL POSITION. 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 9780473 ↗
• InjuryDec 2, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF LEFT FOOT NUMBNESS FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT. HE ALSO ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE BELOW THE MIDDLE IMPLANT TO HELP FIXATE THE JOINT. THE PATIENT REPORTED CONTINUED FOOT NUMBNESS AFTER THE PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9396071 ↗
• InjuryOct 17, 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 PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED UP THE POSITIONED IMPLANT APPROXIMATELY ONE CENTIMETER. NO IMPLANTS WERE REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9202807 ↗
• InjuryNov 8, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE TWO IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE PROCEDURE. X-RAYS INDICATED THAT THE MOST CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND ADDED TWO NEW IMPLANTS IN DIFFERENT POSITIONS. 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 8051334 ↗
• InjuryNov 8, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE ONE IMPLANT WAS PLACED ON EACH SIDE. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF MINIMAL PAIN RELIEF. THE SURGEON DID NOT INDICATE THAT THE IMPLANT WAS MALPOSITIONED OR LOOSE, RATHER HE DETERMINE THAT THE INITIAL SURGEON SHOULD HAVE INSTALLED AT LEAST TWO IMPLANTS AS RECOMMENDED IN THE INSTRUCTIONS FOR USE. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE SOLO IMPLANT ON THE LEFT SIDE AND INSTALLED TWO NEW IMPLANTS OF THE SAME TYPE INTO DIFFERENT POSITIONS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8051257 ↗
• InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2018, THE SURGEON PERFORMED A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT PLACING TWO IMPLANTS ALONG WITH AN ILIOSACRAL SCREW ON A PELVIS TRAUMA CASE. THE PATIENT COMPLAINED OF CONTINUED RADICULOPATHY THAT HE HAD BEFORE THE PROCEDURE. IMAGING CONFIRMED THAT NEITHER OF THE IMPLANTS HAD BREACHED THE NEUROFORAMEN, BUT THE SURGEON DECIDED TO REMOVE THE LONGER IMPLANT AND REPLACE IT WITH A SHORTER IMPLANT AS A PRECAUTION DUE TO THE PATIENT'S HISTORY OF SCIATICA. THREE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE 70 MM IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT, 55 MM, USING THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 7805379 ↗
• InjuryJun 21, 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 RADICULAR LEG PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND REPLACED IT WITH A SHORTER IFUSE IMPLANT USING THE EXPLANT HOLE. THE PATIENT IS DOING FINE FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7627245 ↗
• InjuryFeb 5, 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 RADICULAR PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. FOUR DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT AND REPLACED IT WITH A SHORTER INFUSE IMPLANT. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7242939 ↗
• InjuryNov 21, 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 COMPLAINED OF A TINGLING SENSATION IN HER TOE FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED RIGHT SIDE IMPLANT WAS IRRITATING THE NERVE ROOT. IN (B)(6) 2017, THE SURGEON REMOVED THE CRANIAL IMPLANT AND INSTALLED TWO ADDITIONAL IFUSE IMPLANTS IN NEW POSITIONS. 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 7050927 ↗