ProPlan CMF SD900.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05420060350016), received between Dec 1, 2023 and Dec 21, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K103136); they may or may not involve this specific model.

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.

• MalfunctionDec 21, 2023Positioning Problem; Patient Device Interaction Problem; Positioning Problem; Patient Device Interaction Problem

  KNEE AND FOOT MARKINGS ON FIBULA GUIDE WERE REVERSED. NO INJURY OR NEED FOR REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371009 ↗
• MalfunctionDec 1, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT ON FIBULA GUIDE LABELS FOR KNEE/ANKLE WERE SWAPPED. THIS WAS NOTICED IMMEDIATELY DURING SURGERY, THERE WAS NO PATIENT HARM INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252470 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103136. One submission often covers many models, so check the product and lot details in each record.

• Z-2287-2023 · Jun 19, 2023 · Completed
  ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical proce