Astra Tech Implant System® 25382Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07392532143915), received between Jan 26, 2026 and Sep 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 8 most recent of 8 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 50943294 ↗
• 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 25812554 ↗
• 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 25427526 ↗
• 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 25333765 ↗
• 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 25331371 ↗
• MalfunctionApr 27, 2026Insufficient Device Problem Information

  CUSTOMER REPORTED A PROBLEM WITH AN IMPLANT DRIVER. MORE INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998012 ↗
• 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 24871849 ↗
• MalfunctionJan 26, 2026Fracture

  IT WAS REPORTED THAT A CUSTOMER HAD A FRACTURE IN THE IMPLANT DRIVER PEEK TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176078 ↗