RIALTO™ SI FUSION SYSTEM 7426000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169572546), received between Oct 14, 2024 and Feb 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR BACK PAIN AT T5-T12. IT WAS REPORTED THAT THE DRIVER WAS STRIPPED WHEN TRYING TO REMOVE SCREWS FROM PATIENT UNDER POWER. THE RIALTO DRIVER WAS BROKEN AT THE TIP AND THE TIP WAS RECOVERED FROM THE PATIENT. THE RETRIEVED TIPS OF DRIVERS WERE DISCARDED AT THE FACILITY. THERE WERE NO FRAGMENTS LEFT INSIDE PATIENT BODY. THE EVENT WAS HAPPENED DURING A REVISION CASE, PATIENT REQUIRED A LAMINECTOMY AT T8 <(>&<)> T9. THERE WAS NO ALLEGATION AGAINST THE IMPLANTED HARDWARE RELATED TO THE CASE. THE SURGEON REMOVED AND REPLACED RODS TO GAIN ACCESS FOR A LAMINECTOMY. PROCEDURE WAS T5-T10 HARDWARE REVISION. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351888 ↗
• MalfunctionFeb 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR BACK PAIN AT T5-T12. IT WAS REPORTED THAT THE DRIVER WAS STRIPPED WHEN TRYING TO REMOVE SCREWS FROM PATIENT UNDER POWER. THE RIALTO DRIVER WAS BROKEN AT THE TIP AND THE TIP WAS RECOVERED FROM THE PATIENT. THE RETRIEVED TIPS OF DRIVERS WERE DISCARDED AT THE FACILITY. THERE WERE NO FRAGMENTS LEFT INSIDE PATIENT BODY. THE EVENT WAS HAPPENED DURING A REVISION CASE, PATIENT REQUIRED A LAMINECTOMY AT T8 <(>&<)> T9. THERE WAS NO ALLEGATION AGAINST THE IMPLANTED HARDWARE RELATED TO THE CASE. THE SURGEON REMOVED AND REPLACED RODS TO GAIN ACCESS FOR A LAMINECTOMY. PROCEDURE WAS T5-T10 HARDWARE REVISION. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343340 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVERS USED IN A FUSION. IT WAS REPORTED THAT WHILE INSERTING RIALTO SCREW INTO THE PATIENT, IT WAS UNDERSTOOD THAT THERE WERE ALREADY TWO OTHER SCREWS IN THE PATIENT, SO THIS NEW THIRD SCREW WAS UP AGAINST THE PREVIOUS SCREWS AND THE SURGEON WANTED TO MAKE SURE HE DROVE THE IMPLANT IN ALL THE WAY WHICH ENDED UP TWISTING THE TIP OF THE DRIVER AND BROKE THE TIP. BROKEN TIP OF SCREWDRIVER REMAINED INSIDE THE SCREW IN THE PATIENT, WAS UNABLE TO REMOVE. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE FOUND OUT TO BE PREVIOUSLY FAILED SI FUSION. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE NON NAVIGATED INSTRUMENT TIP WAS LEFT INSIDE THE PATIENT, INSIDE THE IMPLANT. THE NAV TIP WAS TWISTED, NOT SNAPPED. THE GIVEN REVISION SURGERY WAS NOT PERFORMED AS A RESULT OF USE OF MEDTRONIC PRODUCTS. NO ADDITIONAL SURGERY NEEDED TO REMOVE THE BROKEN TIP INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21293403 ↗
• 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 PATIENT'S 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 21262492 ↗
• MalfunctionOct 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING 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 20438044 ↗