ProPlan CMF SD900.051Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420060350511), received between Mar 2, 2018 and Mar 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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.

• InjuryMar 2, 2018Failure to Align; Failure to Align

  A PATIENT SPECIFIC GUIDE WAS USED TO PERFORM A MANDIBLE RECONSTRUCTION. IT WAS REPORTED THAT THE HOLES PRE-DRILLED WITH THE GUIDE DID NOT MATCH UP WITH THE HOLES OF THE PLATE USED IN SURGERY. A DELAY OF AROUND 1 HOUR IN SURGERY WAS REPORTED. SURGEON REPORTED THAT OCCLUSION MAY BE AN ISSUE, BONE SEGMENTS MAY NOT UNITE AS WELL, IMPLANT DIRECTION NOT OPTIMAL, ONLY TWO, INSTEAD OF 4 IMPLANTS WERE PLACED, MORE MANIPULATION OF THE FIBULA SEGMENTS THAT MAY COMPROMISE PART OF FLAP SURVIVAL. SURGEON REPORTED THAT ANOTHER SURGERY WILL BE REQUIRED.

  Patient problems: No Code Available

  MAUDE report 7309143 ↗

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