ASTRA TECH Implant System® EV 25234Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® EV 4.2 S - 11 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 OsseoSpeed dental implant is placed in the jawbone. Most of its 1,080 reports describe the implant failing to bond with the bone or being lost after placement, and some describe fractures or infection. The reports include no deaths and 1,080 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
- 1,107
- Deaths reported
- 0
- Injuries reported
- 1,107
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,107 adverse event reports that list this exact device (DI 07392532132605), received between Mar 16, 2016 and Sep 30, 2026 — classified as 1,107 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (617 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 Osseointegrate617
- Loss of Osseointegration396
- Fracture94
- Crack12
- Off-Label Use3
- Insufficient Device Problem Information1
- Malposition of Device1
Patient problems
- Failure of Implant1,076
- Unspecified Infection262
- Inflammation237
- Pocket Erosion86
- Osteolysis65
- No Clinical Signs, Symptoms or Conditions17
- Inadequate Osseointegration14
- Implant Pain5
Recent adverse event reports
The 25 most recent of 1,107 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 50953087 ↗InjurySep 30, 2026Fracture
It was reported that a patient experienced a dental implant fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950014 ↗InjurySep 30, 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 50949062 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948839 ↗InjurySep 30, 2026Failure to Osseointegrate
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 50945576 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection and progressive bone loss.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50944222 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938259 ↗InjurySep 28, 2026Failure to Osseointegrate
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 50918178 ↗InjurySep 27, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910000 ↗InjurySep 21, 2026Failure to Osseointegrate
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 50837810 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834774 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832429 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832428 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832427 ↗InjurySep 18, 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 50817023 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50812629 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to Periimplantitis.
Patient problems: Inadequate Osseointegration
MAUDE report 50791593 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50791361 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50774190 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50773204 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50769820 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50754398 ↗InjurySep 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50734697 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50725082 ↗InjurySep 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50714141 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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