ASTRA TECH Implant System® 24983Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 3.0 S - 13 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 dental implant is placed in the jawbone. Most of its 330 reports describe implants that were lost or failed to bond with the bone, often with progressive bone loss, and some mention infection or bite overload. The reports include no deaths and 330 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
- 335
- Deaths reported
- 0
- Injuries reported
- 335
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 335 adverse event reports that list this exact device (DI 07392532112133), received between Jun 16, 2023 and Sep 18, 2026 — classified as 335 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (248 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 Osseointegrate248
- Loss of Osseointegration86
- Off-Label Use61
- Fracture1
Patient problems
- Failure of Implant328
- Unspecified Infection111
- Inflammation35
- Pocket Erosion11
- Osteolysis10
- Inadequate Osseointegration5
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 25 most recent of 335 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
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 50820711 ↗InjurySep 18, 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 50817489 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50791423 ↗InjurySep 15, 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 50777964 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50753885 ↗InjurySep 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50733859 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with progressive bone loss.
Patient problems: Failure of Implant; Inadequate Osseointegration; Osteolysis
MAUDE report 50479499 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with progressive bone loss, periimplantitis, and due to occlusal overload.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 50476165 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss due to occlusal overload.
Patient problems: Failure of Implant
MAUDE report 50475654 ↗InjuryAug 26, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50452802 ↗InjuryAug 25, 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 50429431 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced dental implant loss and implant mobility.
Patient problems: Failure of Implant
MAUDE report 50221278 ↗InjuryAug 6, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50154808 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50046602 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; mobility.
Patient problems: Failure of Implant
MAUDE report 50014588 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50003354 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25824913 ↗InjuryJul 8, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; MOBILITY.
Patient problems: Failure of Implant
MAUDE report 25748856 ↗InjuryJul 8, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; MOBILITY.
Patient problems: Failure of Implant
MAUDE report 25748721 ↗InjuryJul 7, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; MOBILITY.
Patient problems: Failure of Implant
MAUDE report 25742040 ↗InjuryJul 7, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; MOBILITY.
Patient problems: Failure of Implant
MAUDE report 25741784 ↗InjuryJul 7, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25732688 ↗InjuryJul 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS/MOBILITY/PERIIMPLANTITIS/2 IMPLANTS INVOLVED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25718788 ↗InjuryJul 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS /MOBILITY/PERIIMPLANTITIS/2 IMPLANTS INVOLVED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25718770 ↗InjuryJun 26, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25636886 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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