ASTRA TECH Implant System® 24449Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Abutment Screw Design 3.5/4.0 - M1.6 · Class 2 · Implant
All models of ASTRA TECH Implant System (166)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Astra Tech abutment screw is the small screw that holds a dental implant crown in place. Most of the 54 reports describe the screw snapping or breaking, sometimes loosening, and in 26 cases the implant itself did not hold. There were no deaths, 45 injuries, and 9 malfunctions. No recalls name this device. Reports rose sharply, from 10 in the prior 12 months to 33 in the last 12 months.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07392532067129), received between Jun 30, 2023 and Sep 29, 2026 — classified as 50 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (58 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture58
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Failure of Implant26
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 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 50933652 ↗InjurySep 29, 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 50933643 ↗InjurySep 28, 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 50914124 ↗InjurySep 28, 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 50914117 ↗InjurySep 28, 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 50914109 ↗InjurySep 28, 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 50914088 ↗InjurySep 28, 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 50914010 ↗InjurySep 28, 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 50914001 ↗InjurySep 11, 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 50737311 ↗InjuryJul 29, 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 50068735 ↗InjuryJun 8, 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 25426627 ↗InjuryJun 8, 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 25426577 ↗InjuryJun 8, 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 25426551 ↗InjuryMay 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25284804 ↗InjuryMay 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210940 ↗MalfunctionApr 27, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25000855 ↗MalfunctionApr 23, 2026Fracture
IT WAS REPORTED THAT A CUSTOMER ENCOUNTERED A DENTAL IMPLANT SCREW FRACTURE AND SUBSEQUENT SCREW EXPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24961886 ↗MalfunctionApr 21, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT ABUTMENT SCREW FRACTURE AND A SUBSEQUENT SCREW LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948418 ↗InjuryApr 7, 2026Fracture
CUSTOMER REPORTED A SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24803987 ↗InjuryApr 3, 2026Fracture
CUSTOMER REPORTED A SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774641 ↗InjuryApr 1, 2026Fracture
CUSTOMER REPORTED A SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755991 ↗InjuryApr 1, 2026Fracture
CUSTOMER REPORTED TWO ABUTMENT AND TWO SCREW FRACTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754448 ↗InjuryMar 31, 2026Fracture
CUSTOMER REPORTED TWO ABUTMENT AND TWO SCREW FRACTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750492 ↗InjuryMar 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ABUTMENT SCREW FRACTURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698330 ↗InjuryMar 19, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW, WITH ASSOCIATED DAMAGE TO THE IMPLANT SHOULDER AND INNER CONNECTION.
Patient problems: Failure of Implant
MAUDE report 24639345 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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