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ANKYLOS® 31010453Recalls & reported problems

Dentsply Implants Manufacturing GmbH · C/X Implant C8 Ø5.5/L8 · Class 2 · Implant

All models of ANKYLOS (112)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Dentsply Ankylos dental implant has 145 FDA adverse event reports, with no deaths and 145 injuries. Most describe the implant failing to fuse with the bone or loosening and being lost. Some mention inflammation, infection or bone loss around the implant. No recalls name this device.

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
148
Deaths reported
0
Injuries reported
148
Recalls naming it
0

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 07392532206177), received between Jun 19, 2023 and Sep 20, 2026 — classified as 148 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (83 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

Nov 2023: 4 reportsDec 2023: 4 reportsJan 2024: 5 reportsFeb 2024: 5 reportsMar 2024: 8 reportsApr 2024: 5 reportsMay 2024: 6 reportsJun 2024: 8 reportsJul 2024: 1 reportsAug 2024: 5 reportsSep 2024: 3 reportsOct 2024: 6 reportsNov 2024: 2 reportsDec 2024: 1 reportsJan 2025: 5 reportsFeb 2025: 5 reportsMar 2025: 9 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 3 reportsAug 2025: 3 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 7 reportsFeb 2026: 5 reportsMar 2026: 8 reportsApr 2026: 4 reportsMay 2026: 1 reportsJun 2026: 4 reportsJul 2026: 4 reportsAug 2026: 2 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate83
  • Loss of Osseointegration63
  • Fracture1
  • Malposition of Device1
  • Migration or Expulsion of Device1

Patient problems

  • Failure of Implant146
  • Inflammation20
  • Unspecified Infection19
  • Osteolysis12
  • Pocket Erosion9
  • No Clinical Signs, Symptoms or Conditions2
  • Paresthesia1
  • Sinus Perforation1

Recent adverse event reports

The 25 most recent of 148 reports, in the reporter's own words as published by the FDA.

  • InjurySep 20, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50834918 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50802903 ↗
  • InjuryAug 27, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50479739 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50223343 ↗
  • InjuryJul 30, 2026Loss of Osseointegration

    It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and inflammation

    Patient problems: Failure of Implant; Inflammation; Unspecified Infection

    MAUDE report 50082455 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    It was reported that a patient experienced a dental implant loss.

    Patient problems: Failure of Implant

    MAUDE report 50006506 ↗
  • InjuryJul 11, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25789274 ↗
  • InjuryJul 11, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25789271 ↗
  • InjuryJun 15, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 25501675 ↗
  • InjuryJun 3, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO MOBILITY.

    Patient problems: Failure of Implant

    MAUDE report 25382866 ↗
  • InjuryJun 3, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO MOBILITY.

    Patient problems: Failure of Implant

    MAUDE report 25382772 ↗
  • InjuryJun 3, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO MOBILITY.

    Patient problems: Failure of Implant

    MAUDE report 25382760 ↗
  • InjuryMay 13, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH PERI-IMPLANTITIS.

    Patient problems: Failure of Implant

    MAUDE report 25159363 ↗
  • InjuryApr 17, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant; Osteolysis

    MAUDE report 24913353 ↗
  • InjuryApr 14, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24871468 ↗
  • InjuryApr 13, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN IMPLANT MOBILITY ISSUE AND A SUBSEQUENT DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24867900 ↗
  • InjuryApr 13, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN IMPLANT MOBILITY ISSUE AND A SUBSEQUENT DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24867897 ↗
  • InjuryMar 25, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24689157 ↗
  • InjuryMar 25, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO AN PERI-IMPLANTITIS AT THE APEX, MOBILITY.

    Patient problems: Failure of Implant; Inflammation

    MAUDE report 24689125 ↗
  • InjuryMar 25, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24684036 ↗
  • InjuryMar 18, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24635633 ↗
  • InjuryMar 18, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24635626 ↗
  • InjuryMar 18, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24635620 ↗
  • InjuryMar 18, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24635614 ↗
  • InjuryMar 16, 2026Loss of Osseointegration

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 24603943 ↗

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Sources and updates

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