ProPlan CMF SD900.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420060351020), received between Apr 27, 2022 and Apr 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Positioning 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 14216828 ↗

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