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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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