MORELAND 2422-46-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295123286), received between Dec 8, 2020 and Jun 24, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2024Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT THE OSTEOTOMES WERE NOT FUNCTIONING AND THEY NEED TO BE REPLACED. NO PATIENT AFFECTED, NO SURGERY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601325 ↗
• MalfunctionJun 9, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE OSTEOTOME WAS WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14646971 ↗
• MalfunctionDec 8, 2020Material Deformation; Material Deformation

  THE INSTRUMENTS ARE DAMAGED. THESE OSTEOTOME BLADES ARE USED ONLY FOR REVISION SURGERY, SINCE RECEIVING THE ITEMS AND COVID RESTRICTIONS, USE OF THESE INSTRUMENTS HAVE BEEN AT LEAST TWICE SINCE PURCHASE. AFTER DECONTAMINATION OF THE INSTRUMENTS, A NOTICEABLE CHANGE IN THE BLADES HAVE BEEN REPORTED BY THE HOSPITAL. THE BLADES ARE BENT AND APPEAR UNUSABLE. THIS KIT HAS SINCE BEEN QUARANTINED AND A REQUEST FROM THE HOSPITAL FOR US TO PLEASE REVIEW AND REPLACE AS THESE ITEMS ARE FAIRLY NEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10970059 ↗