iFuse Implant SystemRecalls & reported problems across all models
Si-Bone Inc. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 410
- Deaths reported
- 1
- Injuries reported
- 409
- Recalls
- 0
We found 28 models of iFuse Implant System by Si-Bone Inc. in the FDA's device registry (GUDID). Together they are named in 410 adverse event reports in the FDA's MAUDE database, received between Aug 31, 2015 and Aug 31, 2023 — classified as 1 death, 409 injuries.
The most frequently reported specific device problem is “Malposition of Device” (336 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported iFuse Implant System problems
Device problems
- Malposition of Device336
- Adverse Event Without Identified Device or Use Problem51
- Loss of Osseointegration24
- Inadequacy of Device Shape and/or Size16
- Failure to Osseointegrate3
- Migration2
- Device Damaged by Another Device1
- Insufficient Device Problem Information1
Patient problems
- Undesired Nerve Stimulation279
- Arthralgia130
- Pain50
- Nerve Proximity Nos (Not Otherwise Specified)45
- Bone Fracture(s)13
- Joint Disorder12
- Fall4
- Hemorrhage/Blood Loss/Bleeding4
iFuse Implant System models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iFuse Implant System 7055M-90Sacroiliac Joint Fixation40 reports
- iFuse Implant System 7060M-90Sacroiliac Joint Fixation34 reports
- iFuse Implant System 7050-90Sacroiliac Joint Fixation34 reports
- iFuse Implant System 7050M-90Sacroiliac Joint Fixation32 reports
- iFuse Implant System 7055-90Sacroiliac Joint Fixation27 reports
- iFuse Implant System 7045M-90Sacroiliac Joint Fixation25 reports
- iFuse Implant System 7040M-90Sacroiliac Joint Fixation22 reports
- iFuse Implant System 7045-90Sacroiliac Joint Fixation21 reports
- iFuse Implant System 7070M-90Sacroiliac Joint Fixation19 reports
- iFuse Implant System 7040-90Sacroiliac Joint Fixation19 reports
- iFuse Implant System 7060-90Sacroiliac Joint Fixation17 reports
- iFuse Implant System 7035M-90Sacroiliac Joint Fixation16 reports
- iFuse Implant System 7070-90Sacroiliac Joint Fixation12 reports
- iFuse Implant System 7070M-100Sacroiliac Joint Fixation11 reports
- iFuse Implant System 7055M-100Sacroiliac Joint Fixation11 reports
- iFuse Implant System 7065M-90Sacroiliac Joint Fixation10 reports
- iFuse Implant System 7035-90Sacroiliac Joint Fixation10 reports
- iFuse Implant System 7065-90Sacroiliac Joint Fixation10 reports
- iFuse Implant System 7075M-90Sacroiliac Joint Fixation7 reports
- iFuse Implant System 7030-90Sacroiliac Joint Fixation7 reports
- iFuse Implant System 7065M-100Sacroiliac Joint Fixation6 reports
- iFuse Implant System 7050M-100Sacroiliac Joint Fixation5 reports
- iFuse Implant System 7060M-100Sacroiliac Joint Fixation5 reports
- iFuse Implant System 7080M-90Sacroiliac Joint Fixation1 death4 reports
- iFuse Implant System 7035M-100Sacroiliac Joint Fixation3 reports
- iFuse Implant System 7040M-100Sacroiliac Joint Fixation1 report
- iFuse Implant System 7045M-100Sacroiliac Joint Fixation1 report
- iFuse Implant System 4040-90Sacroiliac Joint Fixation1 report
Recent iFuse Implant System adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IN (B)(6) 2022, THE SURGEON WAS PERFORMING A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT WHEN HE ENCOUNTERED SIGNIFICANT BLEEDING AFTER BROACHING/IMPACTING FOR THE SECOND IMPLANT. THE SGA OR A BRANCH WAS POSSIBLY DAMAGED. A SINGLE IMPLANT WAS PLACED ADEQUATELY. WHEN THE INSTRUMENTS WERE REMOVED, THE SURGEON OBSERVED EXCESSIVE BLEEDING. PATIENT UNDERWENT COIL EMBOLIZATION OF BRANCH OF THE SGA BY ANOTHER PHYSICIAN. A WEEK LATER, TWO MORE IMPLANTS WERE PLACED WITHOUT INCIDENT. THIS IS A LOW OCCURENCE EVENT AT <.04% OF ALL PROCEDURES PERFORMED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14962187 ↗InjuryApr 1, 2022Malposition of Device; Malposition of Device
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2022 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. DURING THE INITIAL PROCEDURE, THE SURGEON HAD REMOVED THE GUIDE PIN DUE TO PIN ADVANCEMENT AND IMPACTED THE IMPLANT INTO POSITION WITHOUT USING ANY GUIDE PIN AT ALL. DURING INSTALLATION, THE IMPLANT DID NOT FOLLOW THE PRESCRIBED PATH. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. THE DAY AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE 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 13984937 ↗InjuryJan 24, 2022Loss of Osseointegration; Loss of Osseointegration
THE PATIENT IS OSTEOPOROTIC. THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON THOUGHT THAT THE INFERIOR POSITIONED IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND ADDED A NEW IMPLANT OF A DIFFERENT TYPE IN A MORE ANTERIOR POSITION FROM THE INITIAL IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS UNKNOWN.
Patient problems: Arthralgia
MAUDE report 13335097 ↗InjuryJan 13, 2022Malposition of Device; Malposition of Device
THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN FOLLOWING A SHORT PERIOD OF PAIN RELIEF AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED MALPOSITIONING OF THE SUPERIOR IMPLANT BASED ON CT IMAGING AND DECIDED TO REMOVE THE SUPERIOR POSITIONED. WITHIN TWO WEEKS OF THE INITIAL PROCEDURE, A DIFFERENT SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.
Patient problems: Arthralgia; Undesired Nerve Stimulation
MAUDE report 13253298 ↗InjuryJan 6, 2022Malposition of Device; Malposition of Device
THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN DEC 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN POST-SURGERY DURING RECOVERY. THE SUPERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. NEXT DAY, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE SUPERIOR-POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE 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 13173921 ↗InjuryJan 6, 2022Malposition of Device; Malposition of Device
THE PATIENT HAD RIGHT SI JOINT ARTHRODESIS ON (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS NOT POSITIONED FULLY ACROSS THE SI JOINT. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER ONE. HE ALSO ADDED ANOTHER IMPLANT BETWEEN THE SUPERIOR AND MIDDLE IMPLANTS. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.
Patient problems: Arthralgia
MAUDE report 13173915 ↗InjuryDec 29, 2021Malposition of Device; Malposition of Device
THE PATIENT HAS ANOMALOUS PELVIS ANATOMY. THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS ON (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED PSEUDARTHROSIS OF THE JOINT WITH AN ANOMALOUS ALA. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT. NO NEW HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.
Patient problems: Arthralgia; Undesired Nerve Stimulation
MAUDE report 13112754 ↗InjuryDec 22, 2021Malposition of Device; Malposition of Device
THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT POSITIONED FULLY ACROSS THE SI JOINT. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANTS AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE ALSO IMPACTED THE SECOND IMPLANT FURTHER ACROSS JOINT. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS WERE REDUCED FOLLOWING THE REVISION PROCEDURE.
Patient problems: Arthralgia
MAUDE report 13064285 ↗InjuryDec 21, 2021Malposition of Device; Malposition of Device
THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS ON (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN POST-OP. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT IS GETTING BETTER FOLLOWING THE REVISION PROCEDURE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 13057636 ↗InjuryDec 21, 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 DID WELL FOR THREE WEEKS BEFORE REPORTING TO A DIFFERENT SURGEON WITH COMPLAINTS OF RADICULAR PAIN. 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 WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS AS THE IMPLANT WAS SOLIDLY FIXED IN BONE. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 13055387 ↗InjuryDec 6, 2021Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE TWO IMPLANTS WERE INSTALLED TO AUGMENT A DIFFERENT SCREW IN THE JOINT. ON (B)(6) 2021, THE SURGEON REMOVED THE SCREW AND AN ADDITIONAL IMPLANT OF THE SAME TYPE AS THOSE INSTALLED ON (B)(6) 2019. THE SURGEON DETERMINED THAT THE INITIAL CAUDAL POSITIONED IMPLANT WAS TOO SHORT AND INEFFECTIVE. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SHORT IMPLANT AND REPLACED IT WITH A LARGER 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: Arthralgia
MAUDE report 12937443 ↗InjuryNov 29, 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 COMPLAINED OF LEG/FOOT PAIN POST-SURGERY DURING RECOVERY. THE SUPERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. SAME DAY, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE SUPERIOR-POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE 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 12887993 ↗InjuryNov 29, 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 COMPLAINED OF BUTTOCK PAIN POST OP AND PAIN RADIATING DOWN LEG. THE INFERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR-POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE 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 12887921 ↗InjuryNov 23, 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 COMPLAINED OF LEG PAIN POST-OP. THE MIDDLE IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE 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 12862358 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page