Astra Tech Implant System® 25381Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07392532143908), received between Dec 19, 2025 and Sep 29, 2026 — classified as 13 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  It was reported that there was a tool malfunction where the implant driver fractured, and a fractured fragment became lodged in the handle, making it impossible to remove. Session completed with another item.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934697 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931843 ↗
• MalfunctionSep 29, 2026Fracture

  It was reported that there was a tool malfunction where the implant driver has broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930957 ↗
• MalfunctionJun 15, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER DOES NOT HOLD IMPLANTS CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500680 ↗
• MalfunctionJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THERE WAS AN INSERTION PROBLEM AND THE SCREWDRIVER COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457736 ↗
• MalfunctionJun 8, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER DOES NOT HOLD THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427582 ↗
• 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 25334021 ↗
• 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 25331460 ↗
• MalfunctionMay 21, 2026Material Deformation

  IT WAS REPORTED THAT THE IMPLANT HOLDER KEY NO LONGER FITS INTO THE CONTRA-ANGLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241080 ↗
• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE. NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019035 ↗
• MalfunctionApr 14, 2026Mechanical Problem

  CUSTOMER REPORTED THE TOOL ISSUE: THE IMPLANT DRIVER CANNOT GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872108 ↗
• MalfunctionJan 3, 2026Fracture

  THE CUSTOMER REPORTED A TOOL ISSUE: THE DRIVER BROKEN DUE TO EXCESSIVE TORQUE APPLIED BY THE DOCTOR DURING IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953713 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT A CUSTOMER EXPERIENCED AN IMPLANT DRIVER BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846978 ↗