Astra Tech Implant System® EV 26342Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 4.8 S - 9 mm OsseoSpeed® · 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 placed in the jawbone. Most of its 1,191 reports describe implants that fail to fuse with the bone and are lost, with reports also mentioning infection, inflammation or bone loss around the implant. The reports include 1,191 injuries and no deaths. 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
- 1,212
- Deaths reported
- 0
- Injuries reported
- 1,212
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,212 adverse event reports that list this exact device (DI 07392532214417), received between Jun 19, 2023 and Sep 30, 2026 — classified as 1,212 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (882 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 Osseointegrate882
- Loss of Osseointegration282
- Fracture32
- Malposition of Device7
- Insufficient Device Problem Information5
- Difficult to Insert4
- Separation Failure3
- Crack2
Patient problems
- Failure of Implant1,186
- Unspecified Infection259
- Inflammation164
- Osteolysis139
- Pocket Erosion104
- Implant Pain25
- No Clinical Signs, Symptoms or Conditions13
- Inadequate Osseointegration12
Recent adverse event reports
The 25 most recent of 1,212 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection and periimplantitis.09/09/2026 dijcz502 Adding Info from CF. Implant loss.Additional Information/ Description:Graag zon Prime tapen EV 4.8xgmm Retoucncken aam075.Refnn: 68011105.Implant Date - (b)(6) 2020.Explant Date - (b)(6) 2026.Diagnostic result before explantation - Infection , Mobility , Periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50947510 ↗InjurySep 29, 2026Fracture
It was reported that a patient experienced a dental implant fracture.Diagnostic result before explanation - progressive bone loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937390 ↗InjurySep 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Unspecified Infection
MAUDE report 50933742 ↗InjurySep 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50914906 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834772 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832704 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832680 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831670 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827948 ↗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 50820724 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis and progressive bone loss.
Patient problems: Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50816455 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50812941 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50807128 ↗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 50787277 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Concomitant product 4.8 x 9 mm Cover screw.
Patient problems: Inadequate Osseointegration
MAUDE report 50779623 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50779414 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779339 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50766223 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50755838 ↗InjurySep 12, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745435 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50715945 ↗InjurySep 8, 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 50670949 ↗InjuryAug 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495822 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50477644 ↗InjuryAug 26, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50450714 ↗
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- 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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