NA 388.54Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034773445), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE ON (B)(6) 2024, THE SURGEON WAS MAKING A TRACT FOR ILIAC SCREW PLACEMENT. THE BONE WAS HARD, SO THE SURGEON USED A TEFLON MALLET TO MALLET THE PEDICLE PROBE. AFTER A COUPLE OF HITS, THE WOOD HANDLE OF THE PEDICLE PROBE BROKE. A SECOND PROBE WAS USED, AND THE TIP WAS BENT AND TWISTED AS THE SURGEON INSERTED IT. THE SURGEON WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PROBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031668 ↗