DirectGuide™ Drill Extender DGDERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841307119111), received between Dec 11, 2020 and Oct 18, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED

  Patient problems: Failure of Implant

  MAUDE report 17958089 ↗
• InjuryOct 18, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 17958074 ↗
• InjuryJul 18, 2022Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED

  Patient problems: Failure of Implant

  MAUDE report 15042208 ↗
• InjuryJul 18, 2022Separation Failure; Separation Failure

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15042206 ↗
• MalfunctionAug 12, 2021Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURED WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 12311493 ↗
• MalfunctionMar 16, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COULD NOT DRILL USING EDGED.

  Patient problems: Failure of Implant

  MAUDE report 11495331 ↗
• MalfunctionDec 11, 2020Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), FAILURE OF LATCHING FUNCTION LEADS TO FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 10989964 ↗

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