ASTRA TECH Implant System® 24932Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 3.5 S - 11 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 dental implant has 2,574 adverse event reports, with no deaths and 2,572 injuries. Many reports describe implants failing to bond with the jawbone or being lost, with patients reporting infection, inflammation and bone loss. 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
- 2,588
- Deaths reported
- 0
- Injuries reported
- 2,586
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,588 adverse event reports that list this exact device (DI 07392532108372), received between Apr 27, 2023 and Sep 30, 2026 — classified as 2,586 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,206 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
- Failure to Osseointegrate1,206
- Loss of Osseointegration1,190
- Fracture189
- Crack18
- Insufficient Device Problem Information6
- Off-Label Use5
- Damaged Thread4
- Malposition of Device1
Patient problems
- Failure of Implant2,560
- Unspecified Infection556
- Inflammation544
- Osteolysis239
- Pocket Erosion199
- Inadequate Osseointegration18
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 2,588 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50953611 ↗InjurySep 30, 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 50948711 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50948228 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50924018 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50829293 ↗InjurySep 18, 2026Fracture
Customer reports fracture of implant.Date of implant (b)(6) 2018; date of loss: (b)(6) 2026.Customer reports patient has Atrial Fibrillation.
Patient problems: Inadequate Osseointegration
MAUDE report 50821930 ↗InjurySep 18, 2026Fracture
It was reported that a patient experienced a dental implant breakage due to occlusal overload. The dental implant was explanted as a result.
Patient problems: Inadequate Osseointegration
MAUDE report 50821571 ↗InjurySep 17, 2026Fracture
It was reported that a patient experienced a dental implant fracture at the end of the abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807760 ↗InjurySep 16, 2026Osseointegration Problem
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50794614 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50790213 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50776395 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50702920 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702835 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702544 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702318 ↗InjurySep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701884 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50701771 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50701523 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50699744 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss; bone loss.
Patient problems: Osteolysis
MAUDE report 50699640 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50699600 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50699205 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50697530 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695637 ↗InjuryAug 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509779 ↗
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- 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.
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