Astra Tech Implant System® EV 26362Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV 5.4 S - 9 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 Dentsply Astra Tech EV dental implant is placed in the jawbone. The 281 reports mostly describe implants that failed to fuse with the bone or later lost their hold, with patients reporting infection and bone loss. The reports include 280 injuries and no deaths. 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
- 284
- Deaths reported
- 0
- Injuries reported
- 283
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 07392532214547), received between Jun 20, 2023 and Sep 29, 2026 — classified as 283 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (189 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 Osseointegrate189
- Loss of Osseointegration80
- Fracture9
- Insufficient Device Problem Information3
- Malposition of Device3
- Damaged Thread1
Patient problems
- Failure of Implant280
- Unspecified Infection62
- Inflammation34
- Osteolysis31
- Pocket Erosion29
- Implant Pain6
- Inadequate Osseointegration4
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 284 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937793 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50781766 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50779885 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50756965 ↗InjuryAug 26, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50450338 ↗InjuryAug 13, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50236966 ↗InjuryAug 13, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50234045 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50217272 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. An infection was also reported.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50208538 ↗InjuryAug 4, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50132539 ↗InjuryJul 31, 2026Damaged Thread
It was reported that a patient experienced a dental implant removal due to an abutment fracture.
Patient problems: Failure of Implant
MAUDE report 50104952 ↗InjuryJul 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50082736 ↗InjuryJul 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. PATIENT ALSO REPORTED OSTEOLYSIS, INFLAMMATION.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 25850520 ↗InjuryJul 16, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25839519 ↗InjuryJul 14, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25821823 ↗InjuryJul 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. NO OSSEOINTEGRATION ACHIEVED.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25799615 ↗InjuryJul 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25769122 ↗InjuryJul 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH INFECTION.
Patient problems: Failure of Implant
MAUDE report 25761689 ↗InjuryJul 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25731269 ↗InjuryJun 26, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25635733 ↗InjuryJun 22, 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 25578156 ↗InjuryJun 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH INFECTION.
Patient problems: Failure of Implant
MAUDE report 25533153 ↗InjuryJun 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE. ALSO REPORTED WAS PROGRESSIVE BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25522321 ↗InjuryJun 12, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 25486353 ↗InjuryJun 12, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25485947 ↗
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- 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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