Astra Tech Implant System® EV 26323Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 4.2 S - 11 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 is a dental implant placed in the jawbone to hold a replacement tooth. Most reports describe implants that were lost or failed to bond with the bone, and some mention infection, inflammation or bone loss around the implant. The records include 1,981 reports and 1,981 injuries, with no deaths, and 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
- 2,017
- Deaths reported
- 0
- Injuries reported
- 2,017
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,017 adverse event reports that list this exact device (DI 07392532214271), received between Jun 16, 2023 and Sep 30, 2026 — classified as 2,017 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,582 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 Osseointegrate1,582
- Loss of Osseointegration382
- Fracture38
- Insufficient Device Problem Information11
- Adverse Event Without Identified Device or Use Problem4
- Malposition of Device4
- Difficult to Insert2
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant1,986
- Unspecified Infection514
- Inflammation224
- Osteolysis204
- Pocket Erosion133
- Inadequate Osseointegration22
- Implant Pain19
- Insufficient Information11
Recent adverse event reports
The 25 most recent of 2,017 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50946223 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with progressive bone loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50945010 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient experienced a surgical issue during treatment and it was decided to use 4.8 instead of 4.2S.
Patient problems: Insufficient Information
MAUDE report 50943136 ↗InjurySep 29, 2026Patient Device Interaction Problem
It was reported that a patient experienced a dental implant infection. Patient is being treated for infection with antibiotics.
Patient problems: Unspecified Infection
MAUDE report 50935321 ↗InjurySep 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50934775 ↗InjurySep 29, 2026Patient Device Interaction Problem
It was reported that a patient experienced a dental implant loss with infection. Patient is being treated for infection with antibiotics.
Patient problems: Unspecified Infection
MAUDE report 50933409 ↗InjurySep 28, 2026Fracture
It was reported that a patient experienced a dental implant breakage. The dental implant was explanted as a result.
Patient problems: Inadequate Osseointegration
MAUDE report 50918864 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50914595 ↗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 50914415 ↗InjurySep 20, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834725 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832700 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50827155 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with progressive bone loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50822548 ↗InjurySep 17, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809881 ↗InjurySep 17, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection and progressive bone loss.
Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection
MAUDE report 50809821 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; Infection.
Patient problems: Fistula; Inadequate Osseointegration; Unspecified Infection
MAUDE report 50793868 ↗InjurySep 16, 2026Failure to Osseointegrate
Customer reported an implants loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786730 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50781648 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50772132 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50769962 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50765736 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50765720 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50762768 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50758991 ↗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 50757407 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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