ASTRA TECH Implant System® EV 25205Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Abutment Screw EV 4.2 · 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
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07392532143441), received between Mar 6, 2024 and Jun 11, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions2
- Inflammation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25475358 ↗MalfunctionMay 22, 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 25255791 ↗InjurySep 2, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 22947196 ↗InjuryAug 9, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19949683 ↗InjuryMar 6, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 18844784 ↗
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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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