Astra Tech Implant System® 25012Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver 4.5/5.0 Long · Class 1
All models of ASTRA TECH Implant System (166)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07392532119316), received between Feb 19, 2026 and Jul 14, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (14 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem14
- Fracture2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 25813269 ↗MalfunctionJul 7, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER SHAFT BECAME STUCK INSIDE THE EXTENSION. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25737162 ↗MalfunctionJul 7, 2026Insufficient Device Problem Information
IT WAS REPORTED THERE WAS A TOOL ISSUE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25731312 ↗MalfunctionJun 23, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE HEAD OF THE TOOL IS WORN OUT AND CANNOT BE CONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25592511 ↗MalfunctionJun 23, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE HEAD OF THE TOOL IS WORN OUT AND CANNOT BE CONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25592497 ↗MalfunctionJun 22, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THERE WAS DAMAGE TO THE TOOL HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25579868 ↗MalfunctionMay 26, 2026Mechanical Problem
IT WAS REPORTED THAT BOTH IMPLANT DRIVERS REMAINED STUCK IN THE DRILL EXTENSION AND COULD NO LONGER BE REMOVED. THE ISSUE WAS DETERMINED NOT TO BE RELATED TO THE DRILL EXTENSION, AS IT WAS TESTED USING AN OLDER SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285741 ↗MalfunctionMay 18, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER DID NOT RETAIN THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211008 ↗MalfunctionMay 18, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER DID NOT RETAIN THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210995 ↗MalfunctionApr 20, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER DOES NOT PICK UP THE IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926619 ↗MalfunctionApr 14, 2026Fracture
CUSTOMER REPORTED THE TOOL ISSUE: THE IMPLANT DRIVER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876990 ↗MalfunctionApr 8, 2026Mechanical Problem
CUSTOMER REPORTED THE TOOL ISSUE: THE IMPLANT DRIVER CANNOT GET STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816169 ↗MalfunctionApr 8, 2026Mechanical Problem
CUSTOMER REPORTED THE TOOL ISSUE: THE IMPLANT DRIVER CANNOT GET STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816069 ↗MalfunctionApr 1, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER GOT STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753543 ↗MalfunctionApr 1, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER GOT STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753434 ↗MalfunctionMar 31, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER DOES NOT PICK UP THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743402 ↗MalfunctionFeb 19, 2026Mechanical Problem
TOOL ISSUE - IMPLANT DRIVER DOES NOT PICK UP IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389921 ↗MalfunctionFeb 19, 2026Mechanical Problem
TOOL ISSUE - IMPLANT DRIVER DOES NOT PICK UP IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389797 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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