Astra Tech Implant System® EV 26344Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 4.8 S - 13 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 root-form dental implant placed in the jawbone. Its 99 adverse event reports are all injuries, with no deaths, and mostly describe the implant failing to bond with the bone and being lost. Some reports describe infection and bone loss around the implant. 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
- 101
- Deaths reported
- 0
- Injuries reported
- 101
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 07392532214431), received between Jul 10, 2023 and Sep 30, 2026 — classified as 101 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (78 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 Osseointegrate78
- Loss of Osseointegration16
- Fracture6
- Damaged Thread1
- Difficult to Insert1
Patient problems
- Failure of Implant97
- Unspecified Infection21
- Inflammation18
- Osteolysis13
- Pocket Erosion8
- No Clinical Signs, Symptoms or Conditions3
- Implant Pain2
- Discomfort1
Recent adverse event reports
The 25 most recent of 101 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. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949524 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831007 ↗InjurySep 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50736697 ↗InjuryAug 24, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50407877 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50219922 ↗InjuryAug 9, 2026Failure to Osseointegrate
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 50188985 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50006556 ↗InjuryJul 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25762369 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25677355 ↗InjuryJun 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25618969 ↗InjuryJun 22, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH PAIN.
Patient problems: Failure of Implant
MAUDE report 25579153 ↗InjuryJun 8, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO INFECTION.
Patient problems: Failure of Implant
MAUDE report 25431009 ↗InjuryApr 20, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24924559 ↗InjuryApr 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24859438 ↗InjuryApr 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND BONE LOSS.
Patient problems: Failure of Implant
MAUDE report 24834704 ↗InjuryApr 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - INFECTION - OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 24756182 ↗InjuryMar 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24557115 ↗InjuryMar 4, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24512887 ↗InjuryFeb 26, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 24454675 ↗InjuryFeb 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24373906 ↗InjuryFeb 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24303327 ↗InjuryJan 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24228079 ↗InjuryJan 26, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DURING THE HEALING PHASE. ALSO REPORTED WAS AN INFECTION, MISSING OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24179677 ↗InjuryJan 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 23949691 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE. THE DENTAL IMPLANT WAS EXPLANTED AS A RESULT.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 23880005 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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