ProPlan CMF SD900.008 (UDI 05420060350573)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05420060350573), received between Jun 17, 2021 and Jul 2, 2024 — classified as 3 injuries.

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

• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGERY RESULTED IN A POSTERIOR OPEN BITE. CORRECTIVE SURGERY IS REQUIRED.

  Patient problems: Physical Asymmetry

  MAUDE report 19654392 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN FOLLOW-UP MEETING WITH PATIENT, MIDLINE WAS 5MM OFF CENTER AND THERE WAS SIGNIFICANT YAW.

  Patient problems: Physical Asymmetry

  MAUDE report 16931511 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MAXILLA AND MANDIBLE MIDDLINE NOT AS PLANNED AFTER SURGERY.

  Patient problems: Physical Asymmetry

  MAUDE report 12014699 ↗