Step Drill (6-16mml) SD3.4Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307117162), received between Oct 12, 2021 and Apr 19, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPERATED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16767729 ↗
• InjuryApr 11, 2023Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.

  Patient problems: Insufficient Information

  MAUDE report 16712835 ↗
• InjuryMar 24, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.

  Patient problems: Failure of Implant

  MAUDE report 16612340 ↗
• InjuryOct 12, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 12615180 ↗

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