APEX 5018-5-150SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540434777), received between Mar 27, 2019 and Mar 27, 2019 — classified as 1 malfunction.

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

• MalfunctionMar 27, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE APEX PIN WAS INSERTED WITH HANDPIECE AROUND TIBIAL SHAFT PART DURING EXTERNAL FIXATION, THE TIP OF THE PIN (ABOUT 6MM) WAS BROKEN. THE TIP OF THE PIN WAS NOT ABLE TO BE REMOVED AND THE PIN WAS INSERTED OTHER POINT AND THE OPERATION WAS FINISHED. PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8457828 ↗