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GoDirect® Implant Insertion Drill GDIDRecalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307119524), received between Jul 18, 2018 and Jul 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryJul 18, 2018Fracture; Fracture

    PER THE COMPLAINT, THE SHAFT OF THE INSTRUMENT BROKE WHEN TURNING. THIS RESULTED IN THE IMPLANT NOT BEING SET TO PLANNED DEPTH, 1-2 MM TOO HIGH.

    Patient problems: Failure of Implant

    MAUDE report 7701317 ↗

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Sources and updates

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