Hex Tool HT3.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307119654), received between Jun 5, 2019 and Oct 22, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection; Vascular Dissection

  MAUDE report 10716873 ↗
• InjuryJun 5, 2019Separation Failure; Adverse Event Without Identified Device or Use Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  PER COMPLAINT (B)(4), A PATIENT EXPERIENCED AN INTRAORAL INFECTION. DURING CLINICAL PROCEDURE, THE IMPLANT DRIVER GOT STUCK INSIDE THEIR DENTAL IMPLANT. THE IMPLANT WAS REMOVED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8671320 ↗