MORELAND 2422-32-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295123187), received between Dec 7, 2021 and Dec 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE OSTEOTOMES WERE COMPLETELY DAMAGED BEFORE THE OPERATION. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886109 ↗
• 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 19601399 ↗
• MalfunctionNov 2, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THE IMPACTOR HANDLE IS BROKEN. INSTRUMENTS ARE WORN AND UNABLE TO BE ASSEMBLED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715921 ↗
• MalfunctionDec 7, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE OSTEOTOMES ARE BENT AND THE ENDS HAVE A ROUGH EDGE. 1 OPENED AND 2ND STILL IN PACKAGING. THESE HAVE NOT YET BEEN USED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953665 ↗