ASTRA TECH Implant System® EV 25282Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Cover 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
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07392532133794), received between Jul 28, 2023 and Apr 13, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Separation Failure” (9 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 Failure9
- Failure to Osseointegrate2
- Difficult to Remove1
- Fracture1
- Insufficient Device Problem Information1
- Material Deformation1
- Mechanical Problem1
Patient problems
- Failure of Implant10
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Separation Failure
CUSTOMER REPORTED SURGICAL ISSUE (B)(6). COVER SCREW WOULD NOT SIT FLUSH WITH IMPLANT.
Patient problems: Failure of Implant
MAUDE report 24859229 ↗InjuryFeb 24, 2026Separation Failure
IT WAS REPORTED THAT THE COVER SCREW COULD NOT BE REMOVED WHICH LED TO THE EXPLANTATION OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 24436833 ↗InjuryJan 2, 2026Separation Failure
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED A COVER SCREW THAT COULD NOT BE LOOSENED FROM THE IMPLANT AND SUBSEQUENTLY RESULTED IN AN IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23952564 ↗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 23925918 ↗InjuryOct 22, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20504885 ↗InjuryJun 25, 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 19604530 ↗InjuryMar 13, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18893306 ↗InjuryNov 27, 2023Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18209162 ↗InjuryNov 16, 2023Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18147393 ↗InjurySep 18, 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 17769742 ↗InjuryJul 28, 2023Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 17412709 ↗
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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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