ASTRA TECH Implant System® 24930Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 3.5 S - 8 mm · Class 2 · Implant
All models of ASTRA TECH Implant System (166)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Astra Tech OsseoSpeed implant is a screw-shaped device placed into bone. The 1,009 reports mostly describe the implant failing to bond with the bone or coming out, with infection or inflammation also reported. There are 1,008 injury reports, 1 malfunction report 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
- 1,021
- Deaths reported
- 0
- Injuries reported
- 1,020
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,021 adverse event reports that list this exact device (DI 07392532108358), received between Jun 16, 2023 and Sep 30, 2026 — classified as 1,020 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (558 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 Osseointegrate558
- Loss of Osseointegration439
- Fracture24
Patient problems
- Failure of Implant991
- Unspecified Infection237
- Inflammation187
- Osteolysis84
- Pocket Erosion53
- Inadequate Osseointegration16
- No Clinical Signs, Symptoms or Conditions5
- Deformity/ Disfigurement1
Recent adverse event reports
The 25 most recent of 1,021 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Osteolysis
MAUDE report 50950159 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935746 ↗InjurySep 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935621 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Osteolysis
MAUDE report 50698684 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50698609 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50698304 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697986 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss due to Mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50697905 ↗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 50697328 ↗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 50696690 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695634 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50695185 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50695016 ↗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 50694711 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50694165 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50693383 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50692970 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478363 ↗InjuryAug 26, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50464498 ↗InjuryAug 26, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Osteolysis
MAUDE report 50464424 ↗InjuryAug 26, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50464027 ↗InjuryAug 26, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50463894 ↗InjuryAug 26, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50462396 ↗InjuryAug 26, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50461547 ↗InjuryAug 26, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50456984 ↗
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 13, 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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