Sacroiliac Joint Fusion System 1 (REF GSI-SO09540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M719GSISO095400), received between Feb 27, 2026 and Feb 27, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Patient Device Interaction Problem

  THE PATIENT HAD TWO SI JOINT FUSION SURGERIES: HER RIGHT SIDE WAS TREATED ON (B)(6) 2025 AND HER LEFT SIDE WAS TREATED ON (B)(6) 2025. DURING A ROUTINE FOLLOW UP AND CT SCAN, PERFORMED (B)(6) 2025, THE PATIENT HAD NOT FUSED IN EITHER SI JOINT. SOMETIME THEREAFTER, THE PATIENT BEGAN EXPERIENCING LOWER BACK PAIN AND UPPER BUTTOCK PAIN AROUND THE INCISION SITE. SHE BEGAN SEEING A PAIN MANAGEMENT PHYSICIAN. THE PAIN MANAGEMENT PHYSICIAN PERFORMED A LUMBAR RADIOFREQUENCY ABLATION WHICH PRODUCED MINIMAL REDUCTION IN PAIN. THE PAIN MANAGEMENT PHYSICIAN IS NOW DOING STEROID BASED INJECTIONS AS WELL AS MEDICATION MANAGEMENT.

  Patient problems: Back pain; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Pain

  MAUDE report 24475287 ↗