NA 399.13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982202413), received between Feb 1, 2024 and Apr 18, 2024 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DEVICE WAS BROKEN. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) BONE SPREADER 12MM BEAK WIDTH THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140041 ↗
• MalfunctionFeb 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE INSTRUMENT IN QUESTION WORE DOWN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A BONE SPREADER 12MM BEAK WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625866 ↗