Astra Tech Implant System® 25379Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07392532143885), received between Jan 19, 2026 and Sep 30, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  It was reported that the implant driver had insufficient friction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943303 ↗
• MalfunctionSep 29, 2026Fracture

  It was reported that there was a tool malfunction where the driver broke during implant insertion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930987 ↗
• MalfunctionSep 16, 2026Mechanical Problem

  It was reported that there was a tool malfunction where the implant driver will not hold the implant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792481 ↗
• MalfunctionJul 14, 2026Fracture

  IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER IS BROKEN AND CANNOT GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812920 ↗
• MalfunctionJul 13, 2026Fracture

  IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER IS BROKEN AND CANNOT GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807198 ↗
• MalfunctionJun 15, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THAT THE IMPLANT DRIVER NO LONGER HOLDS THE IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500701 ↗
• MalfunctionMay 29, 2026Fracture

  IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED. DRIVER CONNECT WITH SCREWDRIVER HEAD IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338102 ↗
• MalfunctionMay 29, 2026Mechanical Problem

  IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER CANNOT GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334308 ↗
• MalfunctionMay 29, 2026Mechanical Problem

  IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER IS BROKEN AND CANNOT GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331928 ↗
• MalfunctionMay 29, 2026Mechanical Problem

  IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER CANNOT GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331720 ↗
• MalfunctionFeb 19, 2026Mechanical Problem

  IST TOOL MALFUNCTION- TOOL ISSUE-IMPLANT DRIVER DOES NOT PICK UP IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389880 ↗
• MalfunctionJan 19, 2026Fracture

  IT WAS REPORTED AN IMPLANT DRIVER FRACTURED; NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109445 ↗