Astra Tech Implant System® 25384Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV 5.4 Short · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07392532143939), received between Nov 4, 2024 and Jul 16, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem3
- Detachment of Device or Device Component1
- Difficult to Insert1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Failure of Implant1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER NO LONGER GRIPS THE IMPLANT AND THE DRIVER IS STUCK IN THE GRIPPER TOOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25839575 ↗MalfunctionJul 6, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF AN IMPLANT DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25720876 ↗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 25333492 ↗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 25331095 ↗MalfunctionMay 17, 2026Fracture
IT WAS REPORTED THERE WAS A TOOL ISSUE; NO INJURY RESULTED. "BROKEN TIPS ON DRIVERS USED 2 TIMES. SESSION WAS COMPLETED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196391 ↗InjuryNov 4, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20597876 ↗
Other Accessories, implant, dental, endosseous devices
- N/A 68015189Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous388 reports
- N/A 68015191Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous319 reports
- N/A 68015193Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous283 reports
- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
- N/A 68015188Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous185 reports
- N/A 68015192Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous159 reports
- N/A 68015190Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous147 reports
- NobelReplace® 37045Nobel Biocare AB · Accessories, implant, dental, endosseous2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.