ACIS® ProTi 360°™ 108843008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917020434), received between Feb 22, 2025 and Feb 22, 2025 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT WAS IDENTIFIED AS PART OF A RETROSPECTIVE CLINICAL STUDY: 6-MONTHS POST-OPERATIVE SHOW SUBSIDENCE (NOT MEASURED; ONLY THE INTERSPINOUS DISTANCES IN THE FLEXION AND EXTENSION VIEWS) INTO THE SUPERIOR ENDPLATE OF C7 WITH THE GRAFT, WHICH HAS PROGRESSED TO A SOLID FUSION. THERE IS NEUTRAL ALIGNMENT FROM C2 TO T1. THERE IS STILL 3 MM OF MOTION ON FLEXION AND EXTENSION VIEWS, SUGGESTING THAT THE PATIENT IS NOT FULLY FUSED AT THIS POINT 6 MONTHS POSTOPERATIVE. HOWEVER, THE AP VIEW REVEALS BONE GRAFT LATERAL TO THE SPACER ON BOTH SIDES WHICH DOES GENERALLY APPEAR TO BE FUSED, SO CERTAINLY APPROACHING FUSION, BUT NOT QUITE THERE YET. 12.5-MONTHS POST-OPERATIVE SHOW A SOLID FUSION NOW AT C6-7 WITH SOME SUBSIDENCE (MEASUREMENT NOT CAPTURED) OF THE INTERBODY SPACER INTO THE C7 SUPERIOR ENDPLATE AND LESS THAN 1 MM OF MOTION ON FLEXION AND EXTENSION VIEWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440461 ↗