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Step Drill (6-16mml) SD2.3Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 2

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 10841307117148), received between May 10, 2018 and May 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K081396); they may or may not involve this specific model.

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

  • Device-Device Incompatibility1

Patient problems

  • Failure of Implant1
  • No Information1

Recent adverse event reports

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

  • InjuryMay 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

    WHILE DOING GUIDED SURGERY THE DOCTOR FOUND THE DRILLS WOULDN'T MOVE THROUGH THE INSERTS PAST WERE THE NARROW APEX MEETS THE WIDER PART OF DRILL. BECAUSE DOCTOR HAD TO SKIP DRILL IN THE SEQUENCE THEY COULDN'T GET THE CORRECT SIZE OSTEOTOMY AND THE IMPLANT COULDN'T ACHIEVE STABILITY. THIS IS A REPORTABLE SERIOUS INJURY AND DEVICE MALFUNCTION, REQUIRING SECOND SURGERY TO COMPLETE THE PROCEDURE.

    Patient problems: Failure of Implant; No Information

    MAUDE report 7503411 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081396. One submission often covers many models, so check the product and lot details in each record.

  • Z-1126-2020 · Jan 9, 2019 · Terminated
    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
  • Z-1168-2018 · Jan 19, 2018 · Terminated
    SwishPlus Implant Intended for use in support for fixed bridgework.
  • Z-0396-2016 · Oct 28, 2015 · Terminated
    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable

Other Drill, Bone, Powered devices

All Drill, Bone, Powered devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.