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Hex Tool HT2.3Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

All models of Hex Tool (5)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307119623), received between Apr 26, 2019 and Apr 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Device problems

  • Material Deformation1
  • Separation Failure1

Patient problems

  • Failure of Implant1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 26, 2019Separation Failure; Material Deformation; Separation Failure; Material Deformation

    PER COMPLAINT (B)(4) , A HEX TOOL KEY GOT STUCK TO A DENTAL IMPLANT DURING INITIAL PLACEMENT. THE IMPLANT WAS REMOVED AND REPLACED WITH A WIDER IMPLANT ON THE SAME DAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Patient problems: Failure of Implant; No Consequences Or Impact To Patient

    MAUDE report 8558726 ↗

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Sources and updates

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