ASTRA TECH Implant System® 24288Recalls & reported problems
Dentsply Implants Manufacturing GmbH · TiDesign™ 3.5/4.0 - Ø 5.5, 3 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
- 8
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07392532067549), received between Jun 22, 2023 and Sep 22, 2026 — classified as 5 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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
- Fracture8
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Failure of Implant1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852374 ↗InjurySep 21, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50837601 ↗MalfunctionApr 14, 2026Fracture
CUSTOMER REPORTED AN ABUTMENT FRACTURE. NO EXPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876180 ↗InjuryMar 31, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742235 ↗InjuryFeb 11, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317318 ↗MalfunctionFeb 8, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURED ABUTMENT IMPLANT AND A SUBSEQUENT IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288660 ↗MalfunctionDec 19, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857783 ↗InjuryJun 22, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 17181501 ↗
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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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