ProPlan CMF SD900.111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420060351112), received between Oct 22, 2018 and Oct 22, 2018 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K103136, K111558); 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.

• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORAL SURGERY USING PATIENT SPECIFIC GUIDES. CUTS WERE MADE INTO THE TOOTH AND NERVE. THE PATIENT HAD TOOTH AND ROOT DAMAGE. NERVE WAS ANASTOMOSED.

  Patient problems: Nerve Damage

  MAUDE report 7989029 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103136, K111558. 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