Sacroiliac Joint Fusion System 1 (REF GSI206-03)Recalls & reported problems
Genesys Orthopedics Systems LLC · SI Dilator #3 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M719GSI206030), received between Sep 16, 2025 and Sep 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2025Use of Device Problem; Use of Device Problem
DURING A LATERAL SI FUSION PROCEDURE, THE WORKING CHANNEL BEGAN FILLING WITH BLOOD AFTER PLACEMENT OF THE SECOND SI SCREW. THE BLEED WAS DIFFICULT TO CONTROL AND THE PATIENT LOST APPROXIMATELY 750CC OF BLOOD. ONCE THE BLEED WAS CONTROLLED THE PATIENT WAS TRANSFERRED BY AMBULANCE TO A HOSPITAL. WHILE AT THE HOSPITAL, A NEUROSURGEON CONFIRMED THE SI SCREWS WERE PROPERLY PLACED. THE PATIENT WAS RELEASED THE NEXT DAY.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 23068993 ↗
Other Sacroiliac Joint Fixation devices
- Firebird SI Fusion 18-1035SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10065TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10060TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- Firebird SI Fusion 18-2050SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1065SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2065SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2045SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- iFuse TORQ Implant System 10055TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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