APEX 5018-6-150SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540434807), received between Feb 10, 2020 and Feb 10, 2020 — classified as 1 malfunction.

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

• MalfunctionFeb 10, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT DURING EXTERNAL FIXATION FOR A BIMALLEOLAR ANKLE FRACTURE, DURING INSERTION/DRILLING WITH THE ABOVE SELF-TAPPING EXTERNAL FIXATION PIN, THE TIP FRACTURED FROM THE REST OF THE PIN, LEAVING APPROXIMATELY 16 MM OF THE TIP OF THE PIN EMBEDDED IN CORTICAL BONE. THE PIN FRACTURE WAS IDENTIFIED IMMEDIATELY AND THE SURGEON ELECTED TO LEAVE THE RETAINED FRAGMENT IN THE BONE. NO ADVERSE EFFECTS HAVE BEEN NOTED TO DATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9689275 ↗