ASTRA TECH Implant System® EV 25274Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® EV 4.8 C - 11 mm · 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 has 234 adverse event reports, including 234 injuries and no deaths. The reports mostly describe implants failing to bond with the bone or coming loose, and some also mention inflammation, infection, or 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
- 238
- Deaths reported
- 0
- Injuries reported
- 238
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 238 adverse event reports that list this exact device (DI 07392532132810), received between Jun 27, 2023 and Sep 30, 2026 — classified as 238 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (127 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
- Loss of Osseointegration127
- Failure to Osseointegrate68
- Fracture42
- Crack6
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant233
- Inflammation50
- Unspecified Infection40
- Osteolysis26
- Pocket Erosion26
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 25 most recent of 238 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. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949263 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948757 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948700 ↗InjurySep 30, 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 50946602 ↗InjurySep 30, 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 50946357 ↗InjuryAug 6, 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 50155219 ↗InjuryJul 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25849702 ↗InjuryJul 16, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25846695 ↗InjuryJul 15, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. AND ALSO REPORTED WAS OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25825418 ↗InjuryJul 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS/ MOBILITY/1 IMPLANT INVOLVED.
Patient problems: Failure of Implant
MAUDE report 25724830 ↗InjuryJun 30, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25664680 ↗InjuryJun 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; PERIIMPLANTITIS. 2 IMPLANTS INVOLVED.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 25352830 ↗InjuryJun 1, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE. IT WAS ALSO REPORTED THAT THE PATIENT HAD OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25349403 ↗InjuryMay 29, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. AND ALSO REPORTED WAS OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25337660 ↗InjuryMay 29, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25332812 ↗InjuryMay 28, 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 25315339 ↗InjuryMay 22, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25258960 ↗InjuryMay 8, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25128608 ↗InjuryMay 5, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25083794 ↗InjuryApr 27, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25009304 ↗InjuryApr 24, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 24978883 ↗InjuryApr 22, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 24960544 ↗InjuryApr 22, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 24956866 ↗InjuryApr 13, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24858985 ↗InjuryApr 6, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE. THE DENTAL IMPLANT WAS EXPLANTED AS A RESULT.
Patient problems: Failure of Implant
MAUDE report 24790048 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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