Astra Tech Implant System® EV 26313Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 3.6 S - 11 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 Astra Tech EV implant is a root-form dental implant placed in bone. Its 2,957 adverse event reports mostly describe implants that fail to fuse with the bone or later lose that bond, and some report the implant being lost. Bone loss, infection and inflammation are also mentioned. The reports include no deaths and 2,954 injuries. 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
- 3,020
- Deaths reported
- 0
- Injuries reported
- 3,018
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,020 adverse event reports that list this exact device (DI 07392532214202), received between Jun 16, 2023 and Sep 30, 2026 — classified as 3,018 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,470 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 Osseointegrate2,470
- Loss of Osseointegration474
- Fracture54
- Insufficient Device Problem Information10
- Adverse Event Without Identified Device or Use Problem5
- Difficult to Insert4
- Malposition of Device3
- Damaged Thread2
Patient problems
- Failure of Implant2,964
- Unspecified Infection717
- Inflammation349
- Osteolysis312
- Pocket Erosion184
- Implant Pain30
- Inadequate Osseointegration29
- No Clinical Signs, Symptoms or Conditions26
Recent adverse event reports
The 25 most recent of 3,020 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50951483 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50951383 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50945047 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50943302 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923034 ↗InjurySep 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50916980 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50916921 ↗InjurySep 28, 2026Fracture
It was reported that a patient experienced a fracture of a dental Implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914132 ↗InjurySep 28, 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 50913928 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50913449 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Implant is reported to come loose 20 days after being implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912556 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50912377 ↗InjurySep 27, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50910043 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832655 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832209 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50820731 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50820685 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50816379 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis and progressive bone loss.
Patient problems: Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50816316 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50812663 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50806073 ↗InjurySep 16, 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 50785810 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50770960 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50756229 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with Osteolysis.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50755989 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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