ASTRA TECH Implant System® EV 25442Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® Profile EV 4.2 PS - 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 is an Astra Tech OsseoSpeed Profile EV dental implant made by Dentsply. It has 42 adverse event reports, all involving injuries and no deaths; reports mostly describe implants failing to fuse with the jawbone, loosening, or fracturing and being removed, sometimes alongside infection or bone loss. No recalls name this device. Reports have dropped recently, with 3 filed in the latest 12 months compared to 16 in the prior 12 months.
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
- 43
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 07392532137587), received between Jun 13, 2023 and Sep 11, 2026 — classified as 43 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (24 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 Osseointegration24
- Fracture15
- Failure to Osseointegrate5
- Crack3
Patient problems
- Failure of Implant42
- Unspecified Infection14
- Pocket Erosion10
- Inflammation9
- Osteolysis7
- Inadequate Osseointegration1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Fracture
It was reported that a patient experienced a dental implant breakage with bone loss. The dental implant was explanted as a result.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50738825 ↗InjuryJul 8, 2026Loss of Osseointegration
CUSTOMER REPORTED IMPLANT LOSS WITH MOBILITY AND OSTEOLYSIS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 25755402 ↗InjuryApr 23, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. PATIENT ALSO REPORTED PERIIMPLANTITIS, OSTEOLYSIS, PROGRESSIVE BONE LOSS AND AN UNSPECIFIED INFECTION.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24966337 ↗InjuryNov 7, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23504051 ↗InjuryOct 2, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 23201186 ↗InjurySep 10, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 23017685 ↗InjuryAug 19, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 22844222 ↗InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22630238 ↗InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22353037 ↗InjuryMar 26, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21700671 ↗InjuryMar 24, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21677202 ↗InjuryMar 24, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 21677094 ↗InjuryMar 21, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 21664264 ↗InjuryMar 21, 2025Crack; Fracture; Crack; Fracture
THE PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 21661502 ↗InjuryMar 14, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21605039 ↗InjuryMar 12, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21587700 ↗InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21343552 ↗InjuryJan 30, 2025Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21274759 ↗InjuryJan 13, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21138695 ↗InjuryNov 15, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20693468 ↗InjuryOct 16, 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 20460530 ↗InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion; Unspecified Infection
MAUDE report 20006133 ↗InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED, THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20001430 ↗InjuryJul 11, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19718988 ↗InjuryJul 8, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 19688127 ↗
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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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