DS OmniTaper 68011140Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OmniTaper EV Ø3.0 x 11mm OsseoSpeed · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply OmniTaper EV dental implant is a root-form implant placed in the jaw. The 66 adverse event reports mostly describe the implant failing to fuse with the bone so it is lost, often alongside infection, inflammation, and bone loss around the site; a smaller number describe difficulty placing it or use outside its labeling. There are 65 injuries and no deaths. 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
- 67
- Deaths reported
- 0
- Injuries reported
- 66
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 07392532276897), received between Jul 17, 2023 and Sep 8, 2026 — classified as 66 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (64 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 Osseointegrate64
- Off-Label Use13
- Loss of Osseointegration2
- Difficult to Insert1
Patient problems
- Failure of Implant66
- Unspecified Infection15
- Inflammation8
- Osteolysis8
- No Clinical Signs, Symptoms or Conditions1
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 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 50672980 ↗InjuryAug 12, 2026Off-Label Use; Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. The patient also reported to have had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50220097 ↗InjuryAug 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. And also reported was Osteolysis and Unspecified Infection.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 50195831 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50025320 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50009832 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25828983 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25828958 ↗InjuryJul 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25804369 ↗InjuryJul 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25718988 ↗InjuryJul 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25690870 ↗InjuryJul 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25689769 ↗InjuryJun 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25523211 ↗InjuryJun 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25461637 ↗InjuryJun 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25444707 ↗InjuryMay 29, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25333366 ↗InjuryApr 22, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24958619 ↗InjuryApr 21, 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 24948416 ↗InjuryApr 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24884614 ↗InjuryMar 18, 2026Failure to Osseointegrate
CUSTOMER REPORTED AN IMPLANT LOSS DUE TO AN PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 24624651 ↗InjuryMar 3, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS ASSOCIATED WITH MOBILITY AND OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24497592 ↗InjuryFeb 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24419500 ↗MalfunctionFeb 10, 2026Difficult to Insert
IT WAS REPORTED THE IMPLANT COULD NOT BE FULLY INSERTED / BLOCKED AFTER HALF, WHICH RESULTED IN IMPLANT LOSS. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Failure of Implant
MAUDE report 24301201 ↗InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 23811597 ↗InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23811548 ↗InjuryDec 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23797898 ↗
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.
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