ASTRA TECH Implant System® 24893Recalls & reported problems
Dentsply Implants Manufacturing GmbH · 20° UniAbutment 3.5/4.0 - 0.5 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532089954), received between Dec 23, 2025 and Sep 16, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 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 50785844 ↗InjuryMar 30, 2026Fracture
IT WAS REPORTED THERE WAS A FRACTURE OF UNI ABUTMENT AND BRIDGE SCREW. THE IMPLANT IS STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24711776 ↗MalfunctionDec 29, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED LOOSENING OF THREE ABUTMENTS. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905962 ↗MalfunctionDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND SUBSEQUENT IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874526 ↗
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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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