Astra Tech Implant System® EV 26384Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV Profile 4.2 PC - 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 Astra Tech dental implant is a root-form implant placed in the jaw to support dental work. Reports mostly describe implants failing to bond with the bone or loosening later and coming out, sometimes with bone loss and inflammation. There are 23 reports naming its identifier, with no deaths and 23 mentioning injury. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07392532214684), received between Jul 10, 2023 and Sep 30, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 Osseointegrate13
- Loss of Osseointegration7
- Positioning Failure2
- Difficult to Insert1
- Fracture1
Patient problems
- Failure of Implant23
- Osteolysis6
- Inflammation5
- Unspecified Infection2
- Abscess1
- Inadequate Osseointegration1
- Pocket Erosion1
Recent adverse event reports
The 24 most recent of 24 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 with infection and progressive bone loss.
Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection
MAUDE report 50944298 ↗InjuryAug 5, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50140915 ↗InjuryJun 29, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25650631 ↗InjuryJun 24, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25613839 ↗InjuryApr 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO A PERIIMPLANTITIS, GRADUAL BONE LOSS AND INFLAMMATION.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 24830824 ↗InjuryJan 19, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24109202 ↗InjuryNov 11, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23524382 ↗InjuryNov 5, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23482492 ↗InjuryAug 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22696908 ↗InjuryAug 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22696902 ↗InjuryJul 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22551655 ↗InjuryMay 9, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 21997975 ↗InjuryMay 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 21997300 ↗InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 21250867 ↗InjuryOct 21, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 20493582 ↗InjuryJul 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED, THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Pocket Erosion
MAUDE report 19825912 ↗InjuryJun 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19495426 ↗InjuryApr 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 19049457 ↗InjuryJan 31, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18612580 ↗InjuryJan 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18607184 ↗InjuryNov 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18055246 ↗InjurySep 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Abscess; Failure of Implant; Osteolysis
MAUDE report 17710498 ↗InjuryJul 10, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 17288427 ↗InjuryJul 10, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 17288403 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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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