Astra Tech Implant System® 25383Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV 4.8 Long · Class 1
All models of ASTRA TECH Implant System (166)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07392532143922), received between Jan 6, 2026 and Sep 30, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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
- Fracture8
- Mechanical Problem5
- Material Deformation1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
Recent adverse event reports
The 14 most recent of 14 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 50943300 ↗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 25812678 ↗MalfunctionJul 13, 2026Fracture
IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER CANNOT GET STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25798411 ↗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 25333664 ↗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 25331278 ↗MalfunctionMay 29, 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 25330773 ↗MalfunctionMay 4, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073588 ↗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 25019101 ↗MalfunctionApr 15, 2026Separation Failure; Material Deformation
DRIVER WAS STUCK IN THE DRILL EXTENSION, GOT BENT TRYING TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24883767 ↗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 24871821 ↗MalfunctionFeb 19, 2026Mechanical Problem
CUSTOMER REPORTED A TOOL ISSUE - IMPLANT DRIVER DOES NOT PICK UP IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388555 ↗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 24176084 ↗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 24176077 ↗MalfunctionJan 6, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER BROKE WHILE PLACING IMPLANT; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23985846 ↗
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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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