ASTRA TECH Implant System® EV 25481Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Bridge Screw EV · Class 2 · Implant
All models of ASTRA TECH Implant System EV (177)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07392532141690), received between Dec 22, 2025 and Sep 28, 2026 — classified as 12 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (19 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
- Fracture19
Patient problems
- No Clinical Signs, Symptoms or Conditions19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914209 ↗InjurySep 11, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737278 ↗InjurySep 11, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737267 ↗InjurySep 11, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737213 ↗MalfunctionMar 24, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW. THE IMPLANT CAN STILL BE LOADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681318 ↗MalfunctionMar 24, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW. THE IMPLANT CAN STILL BE LOADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681302 ↗MalfunctionMar 24, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW. THE IMPLANT CAN STILL BE LOADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681237 ↗InjuryFeb 19, 2026Fracture
CUSTOMER REPORTED A FRACTURED SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392934 ↗MalfunctionFeb 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384563 ↗InjuryFeb 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE OF SCREWS. THE IMPLANTS ARE STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380652 ↗MalfunctionFeb 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE OF SCREWS. THE IMPLANTS ARE STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380347 ↗InjuryJan 22, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURED BRIDGE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24151463 ↗InjuryJan 15, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURED BRIDGE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080027 ↗MalfunctionDec 26, 2025Fracture; Fracture
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED A FRACTURED DENTAL IMPLANT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23900780 ↗MalfunctionDec 26, 2025Fracture; Fracture
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED A FRACTURED DENTAL IMPLANT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23900776 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURED BRIDGE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879640 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURED BRIDGE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879579 ↗InjuryDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863360 ↗InjuryDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863241 ↗
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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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