ANKYLOS® 31010410 (UDI 07392532206078)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · C/X Implant A11 Ø3.5/L11 · Class 2 · Implant
Quick summary
This Dentsply ANKYLOS dental implant is placed in the jawbone to support a replacement tooth. Its 4,590 adverse event reports mostly describe implants that did not fuse with the jawbone, that were lost, or that broke, and some describe infection, inflammation and bone loss around the implant. The reports include no deaths and 4,588 injuries. 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
- 4,666
- Deaths reported
- 0
- Injuries reported
- 4,664
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,666 adverse event reports that list this exact device (DI 07392532206078), received between Jun 16, 2023 and Sep 30, 2026 — classified as 4,664 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,672 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 Osseointegrate2,672
- Loss of Osseointegration1,556
- Fracture428
- Off-Label Use8
- Adverse Event Without Identified Device or Use Problem7
- Damaged Thread6
- Separation Failure6
- Malposition of Device2
Patient problems
- Failure of Implant4,579
- Unspecified Infection981
- Inflammation728
- Osteolysis479
- Pocket Erosion322
- Inadequate Osseointegration47
- No Clinical Signs, Symptoms or Conditions34
- Implant Pain29
Recent adverse event reports
The 25 most recent of 4,666 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50954458 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50952466 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50948209 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50948156 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50948000 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50947935 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50947328 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50945473 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50945416 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection and periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50945306 ↗InjurySep 29, 2026Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940910 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50933438 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50933322 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Concomitant product: Multiunit abutment + blue Ankylos screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932786 ↗InjurySep 29, 2026Fracture
It was reported that a patient experienced a dental implant fracture resulting in an abutment fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930920 ↗InjurySep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924072 ↗InjurySep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924017 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920678 ↗InjurySep 28, 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 50913728 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50828704 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50828656 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50828632 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50828604 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50828335 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inflammation
MAUDE report 50828171 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.