ASTRA TECH Implant System® 24285Recalls & reported problems
Dentsply Implants Manufacturing GmbH · TiDesign™ 3.5/4.0 - Ø 4.5, 1.5 mm · Class 2 · Implant
All models of ASTRA TECH Implant System (166)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07392532067518), received between Jan 11, 2024 and Sep 21, 2026 — classified as 27 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (27 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
- Fracture27
- Failure to Osseointegrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Failure of Implant6
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843982 ↗InjurySep 20, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833742 ↗InjurySep 18, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820912 ↗InjurySep 18, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820865 ↗InjurySep 16, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw due to infection.
Patient problems: Unspecified Infection
MAUDE report 50786114 ↗InjurySep 16, 2026Fracture
It was reported that a patient experienced a dental abutment breakage that resulted in the removal of the implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786029 ↗InjuryApr 21, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ABUTMENT FRACTURE AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934306 ↗InjuryApr 11, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852587 ↗InjuryApr 3, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774935 ↗InjuryApr 1, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756948 ↗InjuryMar 31, 2026Fracture
IT WAS REPORTED THAT THERE WAS A SCREW FRACTURE WITH IMPLANT REMOVAL.
Patient problems: Failure of Implant
MAUDE report 24750122 ↗InjuryMar 23, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE. THE IMPLANT IS STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663571 ↗InjuryMar 20, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651601 ↗InjuryMar 20, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651557 ↗InjuryMar 19, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639249 ↗InjuryMar 19, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639172 ↗InjuryMar 2, 2026Fracture
ABUTMENT BROKE DURING SCREWING TO THE MODEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489719 ↗MalfunctionFeb 18, 2026Fracture
CUSTOMER REPORTED AN ABUTMENT FRACTURE. DAMAGED ABUTM. IN CROWN + CONR FRAGMENT RECEIVED. PROSTH. RESTOR.:01/2018. OCCURRENCE DATE: 12/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379880 ↗InjuryFeb 17, 2026Fracture
CUSTOMER REPORTED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362236 ↗InjuryJan 16, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096322 ↗InjuryJan 16, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095858 ↗InjuryJan 9, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24024370 ↗InjuryDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872302 ↗InjurySep 16, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20224096 ↗InjuryMay 8, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19269149 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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