Astra Tech Implant System® EV 26333Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 4.2 C - 11 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 is an Astra Tech EV dental implant. The 614 reports all describe injuries, mostly the implant failing to bond with the bone and being lost, with some noting inflammation and infection. There are 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
- 624
- Deaths reported
- 0
- Injuries reported
- 624
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 624 adverse event reports that list this exact device (DI 07392532214349), received between Jun 16, 2023 and Sep 29, 2026 — classified as 624 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (471 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 Osseointegrate471
- Loss of Osseointegration124
- Fracture19
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem2
- Malposition of Device2
- Mechanical Problem2
- Crack1
Patient problems
- Failure of Implant613
- Unspecified Infection109
- Inflammation56
- Osteolysis36
- Pocket Erosion21
- Inadequate Osseointegration7
- No Clinical Signs, Symptoms or Conditions4
- Implant Pain2
Recent adverse event reports
The 25 most recent of 624 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss - Infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50934547 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced an unknown surgical or insertion issue that resulted in implant removal and prolonged surgery.
Patient problems: Inadequate Osseointegration
MAUDE report 50916332 ↗InjurySep 20, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833714 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50824165 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50808638 ↗InjurySep 17, 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 50804258 ↗InjurySep 17, 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 50803427 ↗InjurySep 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50733353 ↗InjurySep 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50733281 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50725146 ↗InjuryAug 24, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50409960 ↗InjuryAug 24, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50407746 ↗InjuryAug 8, 2026Fracture
It was reported that a patient experienced a dental implant fracture.
Patient problems: Failure of Implant
MAUDE report 50185736 ↗InjuryAug 8, 2026Loss of Osseointegration
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 50185281 ↗InjuryAug 5, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50142284 ↗InjuryAug 5, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50141312 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50114143 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50114113 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50113819 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50113803 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50028786 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25822108 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25822061 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25819289 ↗InjuryJul 14, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25812156 ↗
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- 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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