MGUIDE® MG-STN1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07392532253140), received between Feb 25, 2025 and Mar 12, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT WHILE USING A MGUIDE, THE SLEEVE ALREADY FELT VERY TIGHT WHEN USED WITH THE DRILL. DUE TO FRICTION AND HEAT, THE ADHESIVE LOOSENED AND THE SLEEVE CAME LOOSE FROM THE GUIDE, MAKING IT UNUSABLE. THIS CONCERNED AN IMMEDIATE EXTRACTION AND IMPLANT PLACEMENT. AT THIS TIME, ONLY THE EXTRACTION HAS BEEN PERFORMED. AFTER THE EXTRACTION, THE DOCTOR SUTURED THE GUM AND IS NOW ALLOWING IT TIME TO HEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579436 ↗
• InjuryJan 2, 2026Positioning Failure; Insufficient Device Problem Information

  IT WAS REPORTED THAT DESPITE PLANNING IMPLANT PLACEMENT WITH MGUIDE, BONE WAS MISSING. THERE WAS NO PRIMARY-STABILITY, AND THE IMPLANT WAS REPLACED BY A SHORTER IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 23942654 ↗
• InjuryFeb 25, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT AN IMPLANT THAT WAS PLACED USING A MGUIDE IS NOT IN THE SAME POSITION AS ON THE SURGICAL PLAN. THE IMPLANT IS ABOUT 3.3MM TOWARD THE PALATAL AND JUST BARELY IN THE PALATAL CRESTAL BONE. THE DOCTOR REQUESTED A SECOND GUIDE TO BE MANUFACTURED, AND STATED THEY WOULD REMOVE THE FIRST IMPLANT, ADD LINGUAL BONE, AND PLACE THE SECOND IMPLANT. AT THIS TIME, THERE IS NO INDICATION FROM THE DOCTOR REGARDING THE SECOND SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 21459301 ↗