ASTRA TECH Implant System® 24972Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 5.0 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 is a root-form dental implant placed in the jawbone. Of the 602 reports naming it, most describe the implant losing or failing to bond with the bone, with some reporting infection and inflammation. The reports include 601 injuries and 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
- 608
- Deaths reported
- 0
- Injuries reported
- 608
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 608 adverse event reports that list this exact device (DI 07392532108143), received between Jun 22, 2023 and Sep 30, 2026 — classified as 608 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (315 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 Osseointegration315
- Failure to Osseointegrate280
- Fracture16
- Insufficient Device Problem Information2
- Malposition of Device1
- Migration or Expulsion of Device1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant603
- Unspecified Infection182
- Inflammation139
- Pocket Erosion63
- Osteolysis55
- Implant Pain5
- Inadequate Osseointegration4
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 608 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50946095 ↗InjurySep 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with progressive bone loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50915622 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50758140 ↗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 50754114 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740344 ↗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 50478655 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss; periimplantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50229662 ↗InjuryAug 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50194208 ↗InjuryAug 8, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50188119 ↗InjuryAug 7, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. And also reported unspecified Infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50176376 ↗InjuryAug 7, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 50172578 ↗InjuryAug 5, 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 50141377 ↗InjuryAug 5, 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 50141265 ↗InjuryJul 31, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss and also progressive bone loss.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50106626 ↗InjuryJul 31, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50096439 ↗InjuryJul 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50061612 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. And also reported was Osteolysis and inflammation.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 50033951 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had inflammation
Patient problems: Failure of Implant; Inflammation
MAUDE report 50028755 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50019894 ↗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 25826677 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25817786 ↗InjuryJul 14, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25816020 ↗InjuryJul 13, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25797815 ↗InjuryJul 8, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25745923 ↗InjuryJul 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS/PERIIMPLANTITIS/1 IMPLANT INVOLVED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25726850 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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