ASTRA TECH Implant System® EV 25254Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® EV 5.4 S - 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 Astra Tech OsseoSpeed EV dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. The 162 reports describe implants that lost their bond with the jawbone or broke, some with infection, inflammation or bone loss. The reports include no deaths and 162 injuries, and reports fell to 30 in the last 12 months from 55 before. 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
- 166
- Deaths reported
- 0
- Injuries reported
- 164
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 07392532132896), received between Jun 27, 2023 and Sep 30, 2026 — classified as 164 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (97 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 Osseointegration97
- Failure to Osseointegrate45
- Fracture22
- Crack2
- Malposition of Device1
- Mechanical Problem1
- Noise, Audible1
- Overheating of Device1
Patient problems
- Failure of Implant160
- Unspecified Infection42
- Inflammation32
- Pocket Erosion26
- Osteolysis18
- No Clinical Signs, Symptoms or Conditions4
- Implant Pain1
- Inadequate Osseointegration1
Recent adverse event reports
The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
It was reported that a patient experienced a dental implant fracture associated with an infection.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 50943465 ↗MalfunctionSep 30, 2026Fracture
It was reported that while placing an implant, the tip of the carrier broke off inside the implant. The implant was removed and a new one was placed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943324 ↗MalfunctionSep 30, 2026Mechanical Problem; Overheating of Device; Noise, Audible
It was reported that T3 Line EH 40 L experienced rotation defects (abnormal noise, shaft vibration, and heat generation).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943316 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50935985 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50830742 ↗InjurySep 12, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745521 ↗InjuryJun 18, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25549539 ↗InjuryMay 14, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25167342 ↗InjuryMay 12, 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 25148417 ↗InjuryMay 6, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. ALSO, IT WAS REPORTED THAT THEY HAD UNSPECIFIED INFECTION, INFLAMMATION AND OSTEOLYSIS.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25095884 ↗InjuryApr 24, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 24978268 ↗InjuryApr 20, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 24931032 ↗InjuryApr 20, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24930956 ↗InjuryApr 20, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 24925309 ↗InjuryApr 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24830148 ↗InjuryMar 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED IMPLANT MOBILITY ISSUES AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24671488 ↗InjuryFeb 18, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24383966 ↗InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 10, 2026Failure to Osseointegrate
InjuryFeb 10, 2026Failure to Osseointegrate
InjuryFeb 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24283233 ↗InjuryFeb 2, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND PROGRESSIVE BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24233108 ↗InjuryJan 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24221145 ↗InjuryJan 20, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT MOBILITY ISSUE AND IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24113159 ↗
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- 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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