FIXOS 658040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252706991), received between May 15, 2023 and May 15, 2023 — classified as 1 injury.

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

• InjuryMay 15, 2023Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  AS REPORTED: "I HAD A SALES REP THAT CALLED ME IN THE LAST WEEK AND REPORTED THAT HE HAD A FIXOS 2 SCREW THAT THE THREADS RIBBONED AS IT WAS BEING INSERTED. THE SCREW WAS PUT IN ON POWER AND WHEN THE TIP OF THE SCREW WAS DRILLED IT PEELED OUT IN TO NUMEROUS PIECES, THERE WAS NO SHANK LEFT ON THE SCREW. THE SURGEON WAS UNABLE TO GET THE SCREW OUT OF THE PATIENT, SUCCESSFUL COMPRESSION WAS NOT ACHIEVED. THIS CREATED A 20-MINUTE DELAY IN THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16935478 ↗