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Hex Drill HD1.25Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307119548), received between Jul 3, 2019 and Sep 26, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 16, 2026.

Most reported problems

Device problems

  • Fracture2
  • Break1
  • Separation Problem1

Patient problems

  • Failure of Implant3
  • Injury1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 26, 2022Fracture; Fracture

    PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THE HEX DRILL STUCK IN THE HEAL ABUTMENT.

    Patient problems: Failure of Implant

    MAUDE report 15485837 ↗
  • InjurySep 26, 2022Fracture; Fracture

    PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THE HEX DRILL STUCK IN THE HEAL ABUTMENT.

    Patient problems: Failure of Implant

    MAUDE report 15485806 ↗
  • InjuryJul 3, 2019Break; Separation Problem; Break; Separation Problem

    PER COMPLAINT (B)(4), A HEX TOOL BROKE WITHIN A DENTAL IMPLANT DURING THE IMPLANT PROCEDURE. THE TOOL WAS STUCK WITHIN THE TOP PART OF THE IMPLANT. THE PATIENT'S BONE WAS DRILLED AS A CONSEQUENCE.

    Patient problems: Failure of Implant; Injury

    MAUDE report 8761131 ↗

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Sources and updates

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