ASTRA TECH Implant System® 24963Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsseoSpeed® TX 5.0 - 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 implant is a device placed into bone. The 237 reports mostly describe the implant losing its hold in the bone or failing to fuse with it, and some reports mention infection, inflammation and bone loss around it. The reports include 236 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
- 237
- Deaths reported
- 0
- Injuries reported
- 236
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 07392532108204), received between Jun 18, 2023 and Sep 15, 2026 — classified as 236 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (124 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 Osseointegration124
- Failure to Osseointegrate104
- Fracture8
- Difficult to Insert1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant235
- Unspecified Infection50
- Inflammation45
- Osteolysis26
- Pocket Erosion22
- Implant Pain2
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 237 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 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 50774657 ↗InjuryAug 11, 2026Failure to Osseointegrate
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 50207214 ↗InjuryAug 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and inflammation.
Patient problems: Failure of Implant; Implant Pain; Inflammation; Unspecified Infection
MAUDE report 50195694 ↗InjuryJul 27, 2026Failure to Osseointegrate
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 50028577 ↗InjuryJul 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS/MOBILITY/PERI-IMPLANTITIS/4 IMPLANTS INVOLVED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25720404 ↗InjuryJun 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 25437185 ↗InjuryMay 28, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT BREAKAGE. THE DENTAL IMPLANT WAS EXPLANTED AS A RESULT.
Patient problems: Failure of Implant
MAUDE report 25315214 ↗InjuryMay 25, 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 25270269 ↗InjuryMay 22, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25257345 ↗InjuryMay 12, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25155976 ↗InjuryMay 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND A BOWL-SHAPED DEFECT- INFECTION - GRADUAL BONELOSS. ACCORDING TO MEASUREMENTS, THE IMPLANT HAS A DIAMETER OF 5.0 MM AND A LENGTH OF 13 MM.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 25102862 ↗InjuryApr 30, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25048353 ↗InjuryApr 28, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25014037 ↗InjuryApr 16, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24901688 ↗InjuryApr 16, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 24901246 ↗InjuryApr 16, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24899878 ↗InjuryApr 9, 2026Failure to Osseointegrate
InjuryApr 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 24799616 ↗InjuryApr 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 24788947 ↗InjuryApr 2, 2026Loss of Osseointegration
CUSTOMER REPORTED: IMPLANT LOSS - PERI-IMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 24772505 ↗InjuryMar 30, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24727726 ↗InjuryMar 30, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24727581 ↗InjuryMar 30, 2026Loss of Osseointegration
CUSTOMER REPORTED AN IMPLANT LOSS; OCCLUSAL OVERLOAD, PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 24709619 ↗InjuryMar 26, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24699657 ↗InjuryMar 24, 2026Loss of Osseointegration
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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