ProPlan CMF SD900.008 (UDI 05420060350085)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420060350085), received between Sep 7, 2017 and Sep 7, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjurySep 7, 2017Break; Break

  WHEN WIRING THE FINAL SPLINT THE ANTERIOR AREA OF THE SPLINT BROKE AROUND THE WIRING HOLES. THE SURGEON INDICATED THAT THE EVENT DID NOT RESULT IN INJURY OR HARM TO THE PATIENT. THE PATIENT NEEDED A REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 6848040 ↗

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