SIMPLANT® 54500173Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532201820), received between Jun 23, 2026 and Sep 8, 2026 — classified as 2 malfunctions.

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

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.

• MalfunctionSep 8, 2026Separation Failure

  Patient problems: Insufficient Information

  MAUDE report 50677470 ↗
• MalfunctionJun 23, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRILL KEY DID NOT FIT PROPERLY INTO THE GUIDE. THE DRILL KEY WAS STIFF AND WOULDN'T GO IN ALL THE WAY TO THE BASE CAUSING THE IMPLANT PLACEMENT TO BE SLIGHTLY SHALLOWER THAN TYPICAL. THE SESSION COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593697 ↗