ANKYLOS® 31010425 (UDI 07392532206115)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · C/X Implant B8 Ø4.5/L8 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Ankylos implant is a screw placed in the jawbone to hold a replacement tooth. Of its 1,722 reports, 1,721 involve an injury, and most describe the implant being lost, mainly through failure to fuse with the bone or later loss of that bond. Reports also mention infection, inflammation and bone loss around the implant. There are no deaths reported, and 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
- 1,747
- Deaths reported
- 0
- Injuries reported
- 1,746
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,747 adverse event reports that list this exact device (DI 07392532206115), received between Jun 16, 2023 and Sep 30, 2026 — classified as 1,746 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,034 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1,034
- Loss of Osseointegration689
- Fracture18
- Damaged Thread4
- Malposition of Device4
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
Patient problems
- Failure of Implant1,715
- Unspecified Infection285
- Inflammation233
- Osteolysis129
- Pocket Erosion106
- Inadequate Osseointegration19
- No Clinical Signs, Symptoms or Conditions13
- Implant Pain8
Recent adverse event reports
The 25 most recent of 1,747 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955148 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50953995 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50950730 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50938425 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50918195 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834435 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834427 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834403 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50803408 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50779891 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50779858 ↗InjurySep 15, 2026Failure to Osseointegrate
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 50776712 ↗InjurySep 15, 2026Failure to Osseointegrate
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 50774911 ↗InjurySep 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732615 ↗InjurySep 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732192 ↗InjurySep 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50732170 ↗InjurySep 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss due to mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50731393 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723469 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50723006 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50722954 ↗InjurySep 10, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection and occlusal overload.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50714986 ↗InjurySep 10, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss due to infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50713749 ↗InjurySep 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50712839 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50689071 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50689009 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page