RIALTO™ SI FUSION SYSTEM 7426004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169572584), received between Jan 29, 2025 and Feb 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHILE USING THE DRIVER TO REMOVE RIALTO SCREWS FROM THE PATIENT, ONE DRIVER STARTED TO TWIST AND THE OTHER DRIVER'S TIP BROKE OFF. THE TIP WAS RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289590 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280969 ↗
• MalfunctionJan 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT PRESENTED WITH BACK PAIN. IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE RIALTO SCREWS/CAGES FROM THE PATIENTS SACRUM THE ADUSTMENT DRIVER WAS BROKEN. HE THEN ASKED FOR THE T27 THREADED DRIVER AND IT WAS ALSO BROKEN. THE SURGEON DECIDED TO REMOVE THE 6 X BILATERAL RIALTO SCREWS THAT HAD BEEN IMPLANTED ON (B)(6) 2017. THERE WAS NOTHING WRONG WITH THE RIALTO IMPLANTS AND THEY SEEMED SOLIDLY FUSED AND WERE FULL OF BONE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262466 ↗