ASTRA TECH Implant System® EV 25216Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® EV 3.0 S - 15 mm · Class 2 · Implant
All models of ASTRA TECH Implant System EV (177)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply ASTRA TECH EV dental implant is a small screw placed in the jaw to hold a replacement tooth. Reports mostly describe implants loosening or failing to bond with bone and later coming out, with a few fractures and infections mentioned. There are 24 reports naming its identifier, including 24 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07392532132476), received between Aug 14, 2023 and Sep 11, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate19
- Off-Label Use6
- Fracture3
- Loss of Osseointegration3
Patient problems
- Failure of Implant23
- Unspecified Infection3
- Inadequate Osseointegration2
- Pocket Erosion2
- Osteolysis1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50732818 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50698084 ↗InjuryApr 4, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24784601 ↗InjuryMar 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24664261 ↗InjuryMar 18, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED IMPLANT MOBILITY ISSUES AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24635702 ↗InjuryDec 23, 2025Off-Label Use; Loss of Osseointegration; Off-Label Use; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 23881604 ↗InjuryAug 13, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 22794551 ↗InjuryJul 30, 2025Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22672674 ↗InjuryJul 30, 2025Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22672673 ↗InjuryJul 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22401781 ↗InjuryJul 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22401776 ↗InjuryJun 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22352871 ↗InjuryMar 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21728341 ↗InjuryMar 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21559397 ↗InjuryJan 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21051116 ↗InjuryOct 18, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 20479614 ↗InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20005254 ↗InjuryJul 22, 2024Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19790479 ↗InjuryJul 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19740100 ↗InjuryJul 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19691711 ↗InjuryApr 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19213023 ↗InjuryApr 23, 2024Off-Label Use; Loss of Osseointegration; Off-Label Use; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19163851 ↗InjuryFeb 27, 2024Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18789131 ↗InjuryOct 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 17919997 ↗InjuryAug 14, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 17542193 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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