ASTRA TECH Implant System® 24931Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 3.5 S - 9 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 placed into the jawbone. Its 2,068 adverse event reports, all classed as injuries, mostly describe implants being lost or failing to fuse with the bone, and many mention infection, inflammation or bone loss. The reports include 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
- 2,077
- Deaths reported
- 0
- Injuries reported
- 2,077
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,077 adverse event reports that list this exact device (DI 07392532108365), received between Jun 12, 2023 and Sep 30, 2026 — classified as 2,077 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,070 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 Osseointegrate1,070
- Loss of Osseointegration902
- Fracture102
- Crack13
- Off-Label Use7
- Damaged Thread4
- Malposition of Device2
- Migration or Expulsion of Device2
Patient problems
- Failure of Implant2,053
- Unspecified Infection454
- Inflammation422
- Osteolysis201
- Pocket Erosion151
- Inadequate Osseointegration10
- Implant Pain7
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 25 most recent of 2,077 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50954657 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50954581 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948364 ↗InjurySep 29, 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 50936050 ↗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 50933378 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with osteolysis.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50930293 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Osteolysis
MAUDE report 50924074 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50924056 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50916205 ↗InjurySep 10, 2026Fracture
It was reported that a patient experienced a dental implant fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713746 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50482849 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50482767 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with Periimplantitis.
Patient problems: Inflammation
MAUDE report 50479696 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50478731 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50478245 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50478026 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50477208 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50476525 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50476450 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50475764 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50472222 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50472001 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50471815 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Concomitate Product-(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50471383 ↗InjuryAug 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311531 ↗
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.
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