ASTRA TECH Implant System® EV 25214Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® EV 3.0 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 Astra Tech EV dental implant is a screw placed in the jaw bone to support a replacement tooth. Its 741 reports describe the implant failing to fuse with the bone and being lost, with some also mentioning infection, inflammation or bone loss around it. The reports include no deaths and 741 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
- 778
- Deaths reported
- 0
- Injuries reported
- 778
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 778 adverse event reports that list this exact device (DI 07392532132445), received between Jul 10, 2023 and Sep 30, 2026 — classified as 778 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (641 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 Osseointegrate641
- Loss of Osseointegration123
- Off-Label Use102
- Fracture11
- Damaged Thread2
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant741
- Unspecified Infection178
- Inflammation88
- Osteolysis28
- Pocket Erosion25
- No Clinical Signs, Symptoms or Conditions19
- Inadequate Osseointegration18
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 778 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50953363 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952580 ↗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 50949165 ↗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 50946485 ↗InjurySep 29, 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 50935740 ↗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 50917859 ↗InjurySep 20, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834671 ↗InjurySep 20, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834558 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832440 ↗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 50819187 ↗InjurySep 18, 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 50817813 ↗InjurySep 18, 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 50817600 ↗InjurySep 16, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793119 ↗InjurySep 16, 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 50791796 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50757380 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to an infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50755801 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50755605 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50753560 ↗InjurySep 10, 2026Off-Label Use; Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50713581 ↗InjurySep 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50713418 ↗InjurySep 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50713355 ↗InjurySep 10, 2026Off-Label Use; Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50713314 ↗InjurySep 10, 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 50712592 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50698431 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50698133 ↗
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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