ASTRA TECH Implant System® 24943Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 4.0 S - 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 Astra Tech OsseoSpeed dental implant is a screw placed in the jaw bone to support a replacement tooth. Its 732 reports mostly describe the implant failing to fuse with the bone and being lost, and some also mention infection, inflammation or bone loss around it. The reports mention no deaths and 732 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
- 754
- Deaths reported
- 0
- Injuries reported
- 754
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 754 adverse event reports that list this exact device (DI 07392532108327), received between Jun 19, 2023 and Sep 30, 2026 — classified as 754 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (394 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 Osseointegration394
- Failure to Osseointegrate338
- Fracture21
- Insufficient Device Problem Information4
- Malposition of Device1
- Off-Label Use1
Patient problems
- Failure of Implant731
- Unspecified Infection191
- Inflammation167
- Pocket Erosion57
- Osteolysis46
- Inadequate Osseointegration13
- No Clinical Signs, Symptoms or Conditions8
- Implant Pain4
Recent adverse event reports
The 25 most recent of 754 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 50951403 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951350 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951304 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951223 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50947972 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50947886 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50947878 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50947772 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50947759 ↗InjurySep 29, 2026Fracture
Patient problems: Inflammation; No Clinical Signs, Symptoms or Conditions
MAUDE report 50939123 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation; Osteolysis
MAUDE report 50812979 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50788475 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection and pain.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 50774971 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50764486 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50756191 ↗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 50753994 ↗InjurySep 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50734596 ↗InjurySep 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50734546 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50702560 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50697070 ↗InjurySep 8, 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 50672244 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. There was no reported injury. Complaint form not received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667095 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss - Peri-implantitis.
Patient problems: Failure of Implant
MAUDE report 50484338 ↗InjuryAug 20, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with Infection, Mobility, Osteolysis, Progressive Bone Loss, Periimplantitis.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50355724 ↗InjuryAug 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50252021 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page