ACIS® ProTi 360°™ 108843606Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917020656), received between Oct 30, 2024 and Oct 30, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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

• InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate

  ADVERSE EVENT FROM THE CLINICAL STUDY WHO WAS LOST TO FOLLOW-UP. EVENT DETAILS FROM THE SITE ARE AS FOLLOWS: AT 14-MONTHS POST-OPERATIVE, RADIOGRAPHS DEMONSTRATED SOLID FUSION WITH GRAFT INCORPORATION AT C3-C4 AND C4-C5, HOWEVER C5-C6 WAS NOT FUSED; IMAGING DEMONSTRATED PSEUDARTHROSIS AND RADIOLUCENCY ALONG THE INTERFACE WITH THE VERTEBRAL BODY. ADDITIONALLY, IMAGING DETAILS, SEVERE DISC SPACE NARROWING WITH SEVERE ENDPLATE SCLEROSIS INDICATIVE OF ADJACENT LEVEL DISC DISEASE AT THE LEVEL BELOW FUSION. AT THE 17-MONTH POST-OPERATIVE VISIT, THE SUBJECT REPORTED NECK AND ARM PAIN (ARM>NECK), THE SUBJECT DETAILED THAT THE PAIN RADIATES DOWN HER LEFT SHOULDER LEFT THORACIC FLANK, AND LEFT TRICEPS. THE SUBJECT ALSO REPORTED NUMBNESS AND PARESTHESIA IN THE HAND AND FINGERS. THE SUBJECT WAS GIVEN A STEROID INJECTION IN THE LEFT SHOULDER HOWEVER HAD NO MEANINGFUL PAIN RELIEF. THE SURGEON REPORTED 50-60% IMPROVEMENT FROM THE SURGERY. AT 25-MONTHS POST-OPERATIVE, THE RADIOLUCENCY AT C5-C6 WAS STILL PRESENT, HOWEVER THE SUBJECT DECLINED FURTHER TREATMENT AND THE DEVICE REMAINS. THE SUBJECT DID NOT RETURN TO THE CLINIC AFTER THE 25-MONTH POST-OPERATIVE VISIT.

  Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Numbness; Radiolucent Lines

  MAUDE report 20568807 ↗