NA ANCHOR BOLT (REF ACS-025SMS-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03664539000671), received between Aug 31, 2021 and Aug 31, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K170959); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2021Positioning Failure; Positioning Failure

  EVENT DESCRIPTION: THE ANCHOR BOLT WAS BEING INSERTED INTO THE SKULL WHEN THE BOLT THREADS DIDN'T CATCH AND ADVANCED INTO THE PATIENTS BRAIN. PHYSICIAN WAS ABLE TO RETRIEVE THE ANCHOR BOLT AND AN INTRA-OPERATIVE CT WAS PERFORMED. CONCERN EXPRESSED THAT TRAINING AND EDUCATION WAS INADEQUATE. ORIGINAL INTENDED PROCEDURE: STAGE 1 - BILATERAL TWIST DRILLS AND PLACEMENT OF STEREOTACTIC INTRACRANIAL EEG ELECTRODES WITH ROBOTIC STEREOTACTIC ASSISTANCE ROSA AND AIRO PORTABLE CT SCANNER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391356 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170959. One submission often covers many models, so check the product and lot details in each record.

• Z-0541-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0534-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0537-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0536-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0539-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0540-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0535-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0538-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0542-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro