ASTRA TECH Implant System® 24953Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 4.5 - 13 mm · Class 2 · Implant
All models of ASTRA TECH Implant System (166)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Astra Tech OsseoSpeed TX implant appears in 661 adverse event reports, with no deaths and 661 injuries. Reports mostly describe the implant failing to fuse with the jawbone or losing that bond, with patients reporting inflammation, infection and bone loss around the implant. There are no recalls that 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
- 667
- Deaths reported
- 0
- Injuries reported
- 667
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 667 adverse event reports that list this exact device (DI 07392532108259), received between Jun 14, 2023 and Sep 30, 2026 — classified as 667 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (355 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 Osseointegration355
- Failure to Osseointegrate256
- Fracture61
- Crack4
Patient problems
- Failure of Implant658
- Inflammation152
- Unspecified Infection148
- Pocket Erosion64
- Osteolysis58
- Inadequate Osseointegration4
- No Clinical Signs, Symptoms or Conditions4
- Implant Pain1
Recent adverse event reports
The 25 most recent of 667 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 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 50950792 ↗InjurySep 30, 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 50946750 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a fracture of a dental Implant with Infection, and Periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50916306 ↗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 50816514 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50782621 ↗InjurySep 15, 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 50770597 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50756643 ↗InjurySep 14, 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 50756163 ↗InjurySep 11, 2026Fracture
It was reported that a patient experienced a dental implant breakage. The dental implant was explanted as a result.
Patient problems: Inadequate Osseointegration
MAUDE report 50738178 ↗InjuryAug 26, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50462543 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. The patient also reported to have had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50220694 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. The patient also reported to have had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50220625 ↗InjuryAug 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50189098 ↗InjuryAug 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50187127 ↗InjuryAug 7, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50183321 ↗InjuryAug 7, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50181801 ↗InjuryAug 5, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with peri-implantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50141695 ↗InjuryJul 30, 2026Loss of Osseointegration
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 50082245 ↗InjuryJul 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and inflammation, Osteolysis.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50082110 ↗InjuryJul 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and inflammation, Osteolysis.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50082107 ↗InjuryJul 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and Osteolysis.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 50068370 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss/PERIIMPLANTITIS/2 IMPLANTS INVOLVED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50033544 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss; mobility, 2 implants involved.
Patient problems: Failure of Implant
MAUDE report 50019541 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25834398 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25834393 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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