ANKYLOS® 31010423 (UDI 07392532206108)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · C/X Implant B6.6 Ø4.5/L6.6 · 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 is placed into bone, and its 506 reports mostly describe the implant not bonding with the bone or losing its hold, with many describing the implant being lost. Reports also list infection, inflammation, gum tissue erosion, and bone loss around the implant. There are 505 injuries and 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
- 520
- Deaths reported
- 0
- Injuries reported
- 519
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 520 adverse event reports that list this exact device (DI 07392532206108), received between Jun 16, 2023 and Sep 30, 2026 — classified as 519 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (311 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 Osseointegrate311
- Loss of Osseointegration202
- Separation Failure2
- Damaged Thread1
- Difficult to Insert1
- Fluid/Blood Leak1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant505
- Unspecified Infection74
- Inflammation54
- Pocket Erosion48
- Osteolysis37
- Inadequate Osseointegration9
- No Clinical Signs, Symptoms or Conditions6
- Implant Pain3
Recent adverse event reports
The 25 most recent of 520 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953601 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50950836 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50947809 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with progressive bone loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50947154 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932644 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50916643 ↗InjurySep 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50916589 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50831749 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50772262 ↗InjurySep 14, 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 50752068 ↗InjurySep 12, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745783 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50716158 ↗InjurySep 9, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50689132 ↗InjuryAug 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50196342 ↗InjuryAug 10, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50192153 ↗InjuryAug 5, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50146340 ↗InjuryAug 5, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50144453 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50115350 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. And also reported was Osteolysis.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50115249 ↗InjuryAug 3, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. And also reported was Osteolysis
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50113767 ↗InjuryJul 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50082221 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50047996 ↗InjuryJul 27, 2026
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50047993 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50047857 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50047749 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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