RIALTO™ SI FUSION SYSTEM NAV7426001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169571808), received between Oct 14, 2024 and Jun 4, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING REVISION OF RIALTO CAGES. IT WAS REPORTED THAT DURING A REVISION PROCEDURE DRIVER TIPS WERE BROKEN. DRIVERS WERE BROKEN WHEN TRYING TO EXPLANT THE CAGES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. SURGEON HAD TO ALTER SURGICAL PLAN SINCE CAGES COULDN¿T BE REMOVED. AS A RESULT, OTHER PATIENT HARDWARE WAS REVISED. THERE WAS NO MALFUNCTION ASSOCIATED WITH RIALTO CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139368 ↗
• MalfunctionJun 4, 2025Break; Break

  SURGEON HAD TO ALTER SURGICAL PLAN SINCE CAGES COULDN¿T BE REMOVED. AS A RESULT, OTHER PATIENT HARDWARE WAS REVISED. THERE WAS NO MALFUNCTION ASSOCIATED WITH RIALTO CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139251 ↗
• MalfunctionMar 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVER USED IN A POSTERIOR SI FUSION AT LEFT SI. IT WAS REPORTED THAT THE DRIVER BROKE. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DRIVER WAS BROKEN AT THE ONSET OF THE CASE, THE DRIVER WAS NOT USED ON THE PATIENT, AND THERE WAS NO FRAGMENT OF THE DRIVER REMAINING IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500933 ↗
• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING RIALTO NAV DRIVER USED IN NAVIGATED SI FUSION PROCEDURE FOR DEGENERATIVE DISC DISEASE AND SI PAIN. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF AND WAS NO LONGER USABLE. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456288 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A SI FUSION PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENTS BROKE. THE INSTRUMENTS GOT STUCK IN THE NAVIGATED NAV LOCKS. THEY WOULD NOT SPIN WHILE USING THE POWEREASE. THEY ALSO HAD INDENTIONS ON THE SHAFTS. INSTRUMENTS CAME IN CONTACT WITH THE PATIENT. 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 21442894 ↗
• MalfunctionOct 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING SPINAL THERAPY FOR SI SACROILIAC HARDWARE REMOVAL. IT WAS REPORTED THAT THE DEVICE GOT TWISTED THEN TIP BROKE OFF DURING ATTEMPTED REMOVAL. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438041 ↗