ASTRA TECH Implant System® EV 25302Recalls & reported problems
Dentsply Implants Manufacturing GmbH · HealDesign™ EV 4.2 Ø 5 - 4.5 mm · 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
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07392532144615), received between Mar 4, 2024 and Mar 25, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Separation Failure” (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
- Separation Failure5
- Failure to Osseointegrate1
- Fracture1
Patient problems
- Failure of Implant6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Fracture
CUSTOMER REPORTED AN ABUTMENT FRACTURE LEADING TO IMPLANT REMOVAL
Patient problems: Failure of Implant
MAUDE report 24683896 ↗InjuryOct 31, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 23439831 ↗InjuryJan 14, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21147497 ↗InjurySep 13, 2024Failure 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 20212599 ↗InjuryJun 12, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19517999 ↗InjuryMar 4, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18825138 ↗
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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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