Ti6 Internal Fixation System DS2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556835074), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 injury.

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

• InjuryJul 20, 2023Material Disintegration; Flaked; Material Disintegration; Flaked

  IT WAS REPORTED THAT, DURING SURGERY, UPON FINAL TIGHTENING OF ONE (1) TI6 DIGITAL SCREW 2.0 X 30MM THE SCREW HEAD "DISINTEGRATED". SURGEON WAS UNABLE TO ENGAGE THE SCREW TO ADVANCE IT FURTHER DOWN AND UNABLE TO GET THE REMAINDER OF THE SCREW OUT. THE PHYSICIAN USED A MIDAS REX BURR TO BURR IT DOWN ENOUGH TO WHERE HE COULD CLOSE THE INCISION. THE DR. IRRIGATED AND RETRIEVED ALL THE METAL SHAVINGS THAT HE COULD BUT SOME OF THE PATIENTS TISSUE TURNED GRAY FROM THE BURR. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Unspecified Tissue Injury

  MAUDE report 17358337 ↗