Astra Tech Implant System® EV 26302Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 3.0 S - 9 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 is an Astra Tech EV dental implant from Dentsply. Its 257 reports mostly describe implants that did not bond with the bone, leading to implant loss, with some mentioning infection, inflammation and bone loss around the implant. There were no deaths and 257 injuries. 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
- 262
- Deaths reported
- 0
- Injuries reported
- 262
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 07392532214134), received between Jun 19, 2023 and Sep 28, 2026 — classified as 262 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (212 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 Osseointegrate212
- Off-Label Use52
- Loss of Osseointegration42
- Fracture6
- Insufficient Device Problem Information1
- Malposition of Device1
Patient problems
- Failure of Implant254
- Unspecified Infection44
- Inflammation28
- Osteolysis18
- Pocket Erosion15
- No Clinical Signs, Symptoms or Conditions4
- Inadequate Osseointegration3
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 262 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50916041 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant failure.
Patient problems: Inadequate Osseointegration
MAUDE report 50805914 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50766180 ↗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 50755510 ↗InjurySep 12, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746410 ↗InjurySep 12, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746408 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50741071 ↗InjuryAug 25, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441477 ↗InjuryAug 6, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50155898 ↗InjuryAug 5, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50149913 ↗InjuryAug 3, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50115155 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50036205 ↗InjuryJul 27, 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 50006102 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25825051 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. ALSO, IT WAS REPORTED THAT THEY HAD UNSPECIFIED INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25824496 ↗InjuryJul 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25798217 ↗InjuryJul 8, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25750839 ↗InjuryJul 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25689904 ↗InjuryJun 11, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25479479 ↗InjuryMay 28, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25315279 ↗InjuryMay 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. ALSO, IT WAS REPORTED THAT THEY HAD UNSPECIFIED INFECTION AND INFLAMMATION.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 25272333 ↗InjuryMay 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. ALSO, IT WAS REPORTED THAT THEY HAD UNSPECIFIED INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25270228 ↗InjuryMay 20, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. THE IMPLANT WAS PLACED IN A CONTRAINDICATED POSITION.
Patient problems: Failure of Implant
MAUDE report 25233433 ↗InjuryMay 19, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25221611 ↗InjuryMay 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. THE PATIENT ALSO REPORTED THAT THEY HAD INFLAMMATION AND OSTEOLYSIS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 25132663 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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