ASTRA TECH Implant System® EV 25281Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Cover Screw EV 3.6 · 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
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07392532133787), received between Apr 14, 2023 and May 14, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Separation Failure2
- Failure to Osseointegrate1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Fracture
IT WAS REPORTED THAT A PROSTHETIC ISSUE OCCURRED: TWO STRIPPED ASTRA EV 3.6 COVER SCREWS REQUIRED RETRIEVAL TOOLS FOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177388 ↗MalfunctionMay 14, 2026Fracture
IT WAS REPORTED THAT A PROSTHETIC ISSUE OCCURRED: TWO STRIPPED ASTRA EV 3.6 COVER SCREWS REQUIRED RETRIEVAL TOOLS FOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177243 ↗InjuryDec 30, 2025Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23925712 ↗InjuryJun 19, 2025Fracture; Fracture
IN THIS EVENT IT IS REPORTED THAT WHILE PLACING A COVER SCREW EV 3.6 HEALING SCREW IN IMPLANT, SCREW BROKE OFF INSIDE IMPLANT, TRIED TO REMOVE IN REVERSE WITH IMPLANT DRIVER, BUT PLASTIC (FROM IMPLANT DRIVER) THEN ALSO BROKE OFF INSIDE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 22292395 ↗InjuryJun 1, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22120929 ↗InjuryApr 14, 2023Failure to Osseointegrate; Separation Failure; Failure to Osseointegrate; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 16742079 ↗
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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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