ASTRA TECH Implant System® EV 25251Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® EV 5.4 S - 6 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 OsseoSpeed EV dental implant is a root-form implant placed into bone. Its 152 adverse event reports include 151 injuries and no deaths, and most describe implants lost or failing to fuse with the bone, along with infections, inflammation 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
- 155
- Deaths reported
- 0
- Injuries reported
- 154
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 07392532132865), received between Jun 18, 2023 and Sep 15, 2026 — classified as 154 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (82 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 Osseointegration82
- Failure to Osseointegrate70
- Fracture3
- Malposition of Device1
- Off-Label Use1
Patient problems
- Failure of Implant150
- Unspecified Infection24
- Inflammation22
- Osteolysis16
- Pocket Erosion10
- Inadequate Osseointegration3
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 155 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50773901 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50701789 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50699302 ↗InjuryAug 25, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Osteolysis
MAUDE report 50438239 ↗InjuryAug 24, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50410163 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50114210 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; mobility.
Patient problems: Failure of Implant
MAUDE report 50012833 ↗InjuryJul 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS/INFECTION/1 IMPLANT INVOLVED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25853999 ↗InjuryJul 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS/INFECTION/1 IMPLANT INVOLVED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25853765 ↗InjuryJul 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25761801 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25677244 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; MOBILITY.
Patient problems: Failure of Implant
MAUDE report 25677055 ↗InjuryJun 26, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25634386 ↗InjuryJun 26, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25634232 ↗InjuryJun 18, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25546599 ↗InjuryJun 18, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25546293 ↗InjuryJun 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25531722 ↗InjuryJun 15, 2026Off-Label Use; Failure 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 25500696 ↗InjuryJun 12, 2026Failure to Osseointegrate; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25491154 ↗InjuryJun 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; PERI-IMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25449954 ↗InjuryJun 3, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25383022 ↗InjuryJun 3, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25373718 ↗InjuryMay 27, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25299664 ↗InjuryMay 12, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO INFECTION AND PROGRESSIVE BONE LOSS
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 25155392 ↗InjuryMay 7, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. IT WAS REPORTED THAT A PATIENT EXPERIENCED A UNSPECIFIED INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25113302 ↗
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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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