ASTRA TECH Implant System® EV 25213Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® EV 3.0 S - 9 mm · Class 2 · Implant
All models of ASTRA TECH Implant System EV (177)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply OsseoSpeed EV dental implant is a screw-shaped root-form implant used to replace missing teeth. The 75 adverse event reports mostly describe implants that fail to fuse with the bone and are later lost or have to be removed, along with breakage, infection, erosion of the gum pocket and bone loss; all 75 reports involve injuries and no deaths. Reports fell from 19 in the prior 12 months to 10 in the latest 12 months. 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
- 75
- Deaths reported
- 0
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 07392532132438), received between Jun 19, 2023 and Jul 13, 2026 — classified as 75 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (34 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration34
- Failure to Osseointegrate32
- Off-Label Use16
- Fracture8
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant75
- Unspecified Infection19
- Pocket Erosion13
- Inflammation6
- Osteolysis6
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25804423 ↗InjuryJun 4, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT BREAKAGE. THE DENTAL IMPLANT WAS EXPLANTED AS A RESULT. THE IMPLANT WAS PLACED IN A CONTRAINDICATED POSITION.
Patient problems: Failure of Implant
MAUDE report 25389160 ↗InjuryMay 19, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25222569 ↗InjuryMay 12, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. AND ALSO REPORTED WAS OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25151237 ↗InjuryApr 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24911643 ↗InjuryApr 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24911601 ↗InjuryFeb 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24299154 ↗InjuryDec 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23886359 ↗InjuryDec 8, 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
MAUDE report 23736919 ↗InjuryNov 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23637810 ↗InjurySep 12, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23042865 ↗InjuryAug 21, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22860586 ↗InjuryAug 21, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22860475 ↗InjuryJul 30, 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
MAUDE report 22670574 ↗InjuryJul 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22530116 ↗InjuryApr 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Pocket Erosion; Unspecified Infection
MAUDE report 21909210 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 21708718 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21706698 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21706505 ↗InjuryMar 11, 2025Fracture; Fracture
THE PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant; Osteolysis; Pocket Erosion; Unspecified Infection
MAUDE report 21573091 ↗InjuryMar 11, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 21572042 ↗InjuryMar 11, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 21572019 ↗InjuryJan 29, 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; Unspecified Infection
MAUDE report 21262729 ↗InjuryJan 28, 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; Inflammation; Unspecified Infection
MAUDE report 21251717 ↗InjuryJan 27, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21242538 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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