Sacroiliac Joint Fusion System 1 (REF GSI203)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M719GSI2030), received between Jul 12, 2023 and Jul 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionJul 12, 2023Material Fragmentation; Material Fragmentation

  THE COMPLAINANT EMAILED PHOTOS OF A DAMAGED SI DRIVER TO GENESYS SPINE. GENESYS SPINE RECEIVED COMMUNICATION FROM COMPLAINANT THAT THE THREADED TIP OF THE INNER SHAFT OF THE DRIVER BROKE OFF IN THE HEAD OF THE SI SCREW. THE THREADED TIP OF THE SI DRIVER WAS LEFT IN THE SI SCREW THAT WAS IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17311230 ↗