T2 1832-0004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540379764), received between Aug 5, 2021 and Aug 5, 2021 — classified as 1 injury.

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

• InjuryAug 5, 2021Migration; Migration

  THE FOLLOWING WAS REPORTED: THE X-RAYS TAKEN TWO WEEKS LATER SHOWED THAT THE ENDCAP WAS COMING OFF A LITTLE, AND THE X-RAYS TAKEN SEVEN TO EIGHT WEEKS LATER SHOWED THAT IT WAS COMING OFF MORE THAN BEFORE. THE X-RAYS TAKEN TEN MONTHS LATER SHOWED THAT IT WAS ALMOST REMOVED. AT THAT TIME, SINCE THE FUSION WAS NOT YET SECURE, IT WAS DECIDED TO OBSERVE THE PATIENT. IN (B)(6) 2021, IT WAS CONFIRMED THAT THE END CAP WAS COMPLETELY REMOVED. THEREFORE, THE END CAP WAS REMOVED ON (B)(6) IN REVISION SURGERY. THE NAIL WAS NOT REMOVED. THE PATIENT EXPERIENCED PAIN AS A RESULT OF THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 12280762 ↗