ANKYLOS® 31010455Recalls & reported problems
Dentsply Implants Manufacturing GmbH · C/X Implant C9.5 Ø5.5/L9.5 · Class 2 · Implant
All models of ANKYLOS (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Ankylos implant has 122 adverse event reports, with no deaths and 122 injuries. Most reports describe the implant failing to bond with bone or losing that bond, sometimes after bone loss around it, and some mention infection. Reports rose from 15 in the previous year to 36 in the latest year. 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
- 124
- Deaths reported
- 0
- Injuries reported
- 124
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 07392532206047), received between Jun 20, 2023 and Sep 15, 2026 — classified as 124 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (68 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
- Failure to Osseointegrate68
- Loss of Osseointegration54
- Damaged Thread2
- Separation Failure1
Patient problems
- Failure of Implant122
- Unspecified Infection30
- Osteolysis17
- Inflammation14
- Pocket Erosion6
- No Clinical Signs, Symptoms or Conditions2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771168 ↗InjurySep 10, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716336 ↗InjuryAug 14, 2026Failure to Osseointegrate
Patient problems: Failure of Implant
MAUDE report 50253162 ↗InjuryAug 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50252415 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50224354 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss, infection, mobility.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50203725 ↗InjuryAug 10, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50192838 ↗InjuryJul 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to osteolysis.
Patient problems: Failure of Implant
MAUDE report 50052883 ↗InjuryJul 11, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25789275 ↗InjuryJul 11, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25789273 ↗InjuryJul 1, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25679265 ↗InjuryJun 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25526347 ↗InjuryJun 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25442920 ↗InjuryJun 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25418448 ↗InjuryJun 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25367904 ↗InjuryJun 1, 2026Separation Failure
IT WAS REPORTED THAT THE PLACEMENT HEAD SCREW FRACTURED.
Patient problems: Failure of Implant
MAUDE report 25351199 ↗InjuryMay 27, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25304192 ↗InjuryMay 27, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25304184 ↗InjuryMay 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25178071 ↗InjuryMay 7, 2026Damaged Thread
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25112162 ↗InjuryApr 29, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25024289 ↗InjuryApr 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24905254 ↗InjuryApr 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN IMPLANT MOBILITY ISSUE AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24867960 ↗InjuryMar 19, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24637957 ↗InjuryMar 4, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24514350 ↗
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- 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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