RISE 193.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095213416), received between Dec 10, 2020 and Nov 20, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Migration; Migration

  IT WAS REPORTED THAT A RISE WAS INSERTED INTO L4/5. AFTER EXPANDING THE RISE, THE SURGEON REVIEWED THE IMAGES AND NOTICED SPACE ANTERIOR INTERVERTEBRAL. THE SURGEON THEN LOWERED THE RISE HEIGHT AND INSERTED IT FURTHER. UPON RE-EXPANDING THE RISE AND REVIEWING THE IMAGES, IT WAS FOUND TO BE OVER-INSERTED. THE SURGEON ATTEMPTED TO CORRECT THE POSITION USING THE INSERTER, BUT THE RISE DISLODGED FROM THE INSERTER. REVIEWING THE IMAGES REVEALED THE RISE HAD DROPPED ANTERIORLY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. THE RISE WAS REMOVED FROM THE PATIENT AT THE HOSPITAL ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 23605382 ↗
• InjuryOct 28, 2025Migration; Migration

  IT WAS REPORTED THAT RISE IMPLANTS WERE INSERTED AT L3/4/5 BY PLIF ON (B)(6) 2025. AFTER REVIEW OF IMAGE, THE SURGEON DECIDED TO RE-POSITION THE RISE AT RIGHT L4/5. THE SURGEON INSERTED THE INSERTER INTO RIGHT L4/5 TO REPOSITION BUT ACCIDENTALLY PUSHED THE RISE WITH THE INSERTER, CAUSING IT TO FALL VENTRALLY. A NEW RISE WAS INSERTED INTO RIGHT L4/5 AND THE FIXATION PROCEDURE WAS COMPLETED. ON (B)(6) 2025, THE RISE THAT HAD FALLEN INTO THE VENTRAL SPACE WAS REMOVED AT ANOTHER HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 23407579 ↗
• MalfunctionNov 16, 2022Migration

  IT WAS REPORTED THERE WAS A REVISION SURGERY TO REPLACE A RISE SPACER THAT MIGRATED POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.

  Patient problems: Failure of Implant

  MAUDE report 15803986 ↗
• MalfunctionDec 10, 2020Collapse

  IT WAS REPORTED THAT A RISE SPACER COLLAPSED POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10987369 ↗