RIALTO™ SI FUSION SYSTEM 74200001250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169571846), received between May 13, 2019 and May 13, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 DUE TO "ISG" PAIN ON THE LEFT SIDE WITH PRONOUNCED INSTABILITY. THE ALLEGED IMPLANT WAS IMPLANTED IN THIS SURGERY. NO COMPLICATIONS WERE EXPERIENCED DURING SURGERY. AFTER INITIALLY 2 WEEKS OF STRONG FEELINGS OF TENSION, THE PAIN IMPROVED. HENCE, OPERATION FOR ISG STIFFENING WAS DONE AT RIGHT SIDE WITH THE SAME IMPLANT ON (B)(6) 2019. HOWEVER, FROM MID-MARCH, THERE WAS A STRONG INCREASE IN PAIN AGAIN; HENCE, A FOLLOW-UP WAS DONE (B)(6) 2019. FOLLOW-UP X-RAY DATED (B)(6) 2019 SHOWED A HALO AROUND THE IMPLANTS. ACCORDING TO THE SURGEON, THIS WAS DUE TO LOOSENING OF THE LEFT IMPLANTS. HENCE, ON (B)(6) 2019, THE IMPLANTS WERE EXPLANTED AND WERE REPLACED WITH PRODUCTS FROM OTHER MANUFACTURER. THE REVISION SURGERY WENT WELL, WITHOUT ANY COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 8604763 ↗
• InjuryMay 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 DUE TO "ISG" PAIN ON THE LEFT SIDE WITH PRONOUNCED INSTABILITY. THE ALLEGED IMPLANT WAS IMPLANTED IN THIS SURGERY. NO COMPLICATIONS WERE EXPERIENCED DURING SURGERY. AFTER INITIALLY 2 WEEKS OF STRONG FEELINGS OF TENSION, THE PAIN IMPROVED. HENCE, OPERATION FOR ISG STIFFENING WAS DONE AT RIGHT SIDE WITH THE SAME IMPLANT ON (B)(6) 2019. HOWEVER, FROM MID-(B)(6), THERE WAS A STRONG INCREASE IN PAIN AGAIN; HENCE, A FOLLOW-UP WAS DONE (B)(6) 2019. FOLLOW-UP X-RAY DATED: (B)(6) 2019 SHOWED A HALO AROUND THE IMPLANTS. ACCORDING TO THE SURGEON, THIS WAS DUE TO LOOSENING OF THE LEFT IMPLANTS. HENCE, ON (B)(6) 2019, THE IMPLANTS WERE EXPLANTED AND WERE REPLACED WITH PRODUCTS FROM OTHER MANUFACTURER. THE REVISION SURGERY WENT WELL, WITHOUT ANY COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 8604720 ↗