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Hex Drill HD2.7Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

Data updated Oct 13, 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 10841307119586), received between Nov 21, 2018 and Nov 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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

Device problems

  • Incomplete or Missing Packaging1

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.

  • MalfunctionNov 21, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

    PER COMPLAINT (B)(4), A MISSING O-RING ON A HEX DRILL CAUSED THE DENTIST TO DROP A DENTAL IMPLANT INSIDE THE PATIENT'S MOUTH DURING PLACEMENT. THE PROCEDURE WAS COMPLETED WITHIN THE SAME PROCEDURE WITH ANOTHER IMPLANT. THERE WAS NO PATIENT IMPACT AS A RESULT OF THE EVENT.

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

    MAUDE report 8096557 ↗

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Sources and updates

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