ANKYLOS® 31056022Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Fixation Screw, occlusal M1.6 mm Hex · Class 2 · Implant
All models of ANKYLOS (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07392532222146), received between Dec 23, 2025 and Aug 28, 2026 — classified as 14 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (15 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
- Fracture15
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information1
- Osteolysis1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Fracture
It was reported that a patient experienced a fracture of the dental screw inside the implant, making it impossible to remove.
Patient problems: Insufficient Information
MAUDE report 50506767 ↗InjuryApr 7, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW. THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO REMOVE THE FRACTURED SCREW FROM THE ABUTMENT AND THEREFORE HAD TO REPLACE THE ENTIRE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800267 ↗InjuryJan 19, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24107898 ↗InjuryJan 14, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis
MAUDE report 24072556 ↗MalfunctionDec 25, 2025Fracture; Fracture
IT WAS REPORTED THAT AN IMPLANTED SCREW BROKE AND SUBSEQUENTLY RESULTED IN IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894517 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FOURFOLD SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879381 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FOURFOLD SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879329 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FOURFOLD SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879304 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FOURFOLD SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879262 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL IMPLANT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875773 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL IMPLANT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875754 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL IMPLANT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875743 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL IMPLANT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875733 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL IMPLANT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875696 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL IMPLANT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875673 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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