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Astra Tech Implant System® 26021Recalls & reported problems

Dentsply Implants Manufacturing GmbH · Implant Driver Extender EV-GS · Class 1

All models of ASTRA TECH Implant System (166)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07392532168604), received between Feb 19, 2026 and Jul 14, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 3 reportsApr 2026: 2 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem6
  • Loose or Intermittent Connection3
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions9

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 14, 2026Mechanical Problem

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A TOOL MALFUNCTION WHERE THE DRIVER IS STUCK IN THE DRILL EXTENSION; HOWEVER, THE SESSION WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25815200 ↗
  • MalfunctionMay 27, 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 25306903 ↗
  • MalfunctionMay 27, 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 25306497 ↗
  • MalfunctionApr 17, 2026Mechanical Problem

    CUSTOMER REPORTED TOOL MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24915361 ↗
  • MalfunctionApr 14, 2026Loose or Intermittent Connection; Mechanical Problem

    IT WAS REPORTED THAT THE EXTENDER DOES NOT HOLD THE ROTARY TOOL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24873172 ↗
  • MalfunctionMar 24, 2026Loose or Intermittent Connection

    IT WAS REPORTED THAT THERE WAS INSUFFICIENT FRICTION OF THE IMPLANT DRIVERS IN THE DRIVER EXTENDER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24681264 ↗
  • MalfunctionMar 24, 2026Loose or Intermittent Connection

    IT WAS REPORTED THAT THE IMPLANT DRIVER GOT STUCK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24674881 ↗
  • MalfunctionMar 17, 2026Mechanical Problem

    IT WAS REPORTED THAT AN IMPLANT DRIVER HAD A DEFORMED EXTENSION AND THE DRILL BITS NO LONGER FIT IN THE EXTENSION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24617988 ↗
  • MalfunctionFeb 19, 2026Fracture

    IT WAS REPORTED A TOOL MALFUNCTION. THE IMPLANT DRIVER DID NOT HOLD SECURELY. DURING INITIAL USE, THE SESSION WAS COMPLETED WITH ANOTHER ITEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24387890 ↗

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Sources and updates

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