Astra Tech Implant System® EV 26340Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 4.8 S - 6 mm OsseoSpeed® · 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 Astra Tech Implant EV dental implant has 345 adverse event reports on file, with no deaths and 345 injuries. Most reports say the implant failed to bond with the jawbone, and some mention inflammation, infection or bone loss around it. 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
- 355
- Deaths reported
- 0
- Injuries reported
- 355
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 07392532214394), received between Jun 21, 2023 and Sep 30, 2026 — classified as 355 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (236 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
- Failure to Osseointegrate236
- Loss of Osseointegration115
- Fracture2
- Insufficient Device Problem Information2
- Malposition of Device2
- Off-Label Use1
Patient problems
- Failure of Implant348
- Inflammation55
- Unspecified Infection45
- Osteolysis29
- Pocket Erosion24
- Implant Pain6
- Inadequate Osseointegration5
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 355 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953207 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50949536 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50828644 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50766211 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753482 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50672549 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50670238 ↗InjuryAug 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50257486 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50224760 ↗InjuryAug 10, 2026Malposition of Device
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50193538 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss and also reported Osteolysis.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50113623 ↗InjuryJul 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50068607 ↗InjuryJul 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; periimplantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50061197 ↗InjuryJul 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; periimplantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50060648 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50048208 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; periimplantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50025345 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50025145 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25826845 ↗InjuryJul 11, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. AND ALSO REPORTED WAS OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25789245 ↗InjuryJul 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25765543 ↗InjuryJul 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25731581 ↗InjuryJul 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25731563 ↗InjuryJul 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25717507 ↗InjuryJul 2, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - PATIENT CAME TO THE OFFICE WITH A FALLEN-OUT IMPLANT.
Patient problems: Failure of Implant
MAUDE report 25689958 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25681173 ↗
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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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