Astra Tech Implant System® EV 26334Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 4.2 C - 13 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 Dentsply Astra Tech EV dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Its 143 reports mostly describe implants that failed to bond with the bone and were then lost, and some mention infection around the implant. There are no deaths and 143 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
- 144
- Deaths reported
- 0
- Injuries reported
- 144
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 07392532214356), received between Jun 29, 2023 and Aug 16, 2026 — classified as 144 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (113 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 Osseointegrate113
- Loss of Osseointegration26
- Fracture3
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant144
- Unspecified Infection25
- Inflammation13
- Pocket Erosion8
- Osteolysis7
- Implant Pain1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 144 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50263743 ↗InjuryJul 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50068906 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss, Infection, Periimplantitis.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 50046612 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25813245 ↗InjuryJul 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS / LOOSENING.
Patient problems: Failure of Implant
MAUDE report 25777950 ↗InjuryJun 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25461437 ↗InjuryJun 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25461417 ↗InjuryJun 3, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25373528 ↗InjuryMay 29, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WHEN SECURING THE ABUTMENT.
Patient problems: Failure of Implant
MAUDE report 25334736 ↗InjuryMay 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION, PERIIMPLANTITIS, TRANSLATION: POOR BONE INTEGRATION.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 25112037 ↗InjuryMay 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25109981 ↗InjuryApr 24, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO BUCCAL BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24981939 ↗InjuryApr 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24867354 ↗InjuryApr 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24834734 ↗InjuryApr 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24832587 ↗InjuryApr 3, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. IMPLANT WAS MOBILE WHEN PATIENT CAME BACK FOR INTEGRATION CHECK; HAD TO BE REMOVED.
Patient problems: Failure of Implant
MAUDE report 24778274 ↗InjuryMar 23, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24661732 ↗InjuryMar 19, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24644503 ↗InjuryMar 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24558422 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24554875 ↗InjuryMar 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO MOBILITY.
Patient problems: Failure of Implant
MAUDE report 24534099 ↗InjuryFeb 26, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO AN INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24457245 ↗InjuryFeb 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24449276 ↗InjuryFeb 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24416195 ↗InjuryFeb 2, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24231100 ↗
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- 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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