"3M™ ESPE™ MDI Max with O-Ball Head and Collar 2.4 mm x 10 mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30605861053915), received between Jun 20, 2018 and Jun 20, 2018 — classified as 1 injury.

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 18, 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.

• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 A DENTIST FROM (B)(6) REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT HAD A 3M¿ ESPE¿ 2.4X10MM MDI O-BALL PROSTHETIC HEAD - COLLARED (MOB-10) IMPLANT FRACTURED. ON (B)(6) 2018 IT WAS REPORTED TO 3M THAT THE IMPLANT WAS SURGICALLY REMOVED WITHOUT COMPLICATION USING A LINDEMANN BURR. THE CURRENT PATIENT STATUS WAS REPORTED TO BE FINE. THE IMPLANT WAS PLACED IN THE UPPER JAW IN (B)(6) 2013. THE REASON FOR IMPLANT BREAKAGE COULD NOT BE DETERMINED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7622024 ↗