DS OmniTaper 68011145Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OmniTaper EV Ø3.4 x 13mm OsseoSpeed · Class 2 · Implant
All models of DS OmniTaper (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply OmniTaper dental implant has 108 adverse event reports, with no deaths and 108 injuries. Most reports describe the implant failing to bond with the jawbone or being lost, and some mention infection or bone loss. 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
- 109
- Deaths reported
- 0
- Injuries reported
- 109
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 07392532276941), received between Jul 5, 2023 and Sep 30, 2026 — classified as 109 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (98 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 Osseointegrate98
- Loss of Osseointegration11
Patient problems
- Failure of Implant108
- Unspecified Infection24
- Osteolysis17
- Inflammation12
- Pocket Erosion4
- Abscess2
- Inadequate Osseointegration1
Recent adverse event reports
The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50945224 ↗InjuryAug 6, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and Osteolysis.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 50150678 ↗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 50115469 ↗InjuryAug 3, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50115103 ↗InjuryAug 3, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50114903 ↗InjuryJul 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25785235 ↗InjuryJul 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - INFECTION, MISSING OSSEOINTEGRATION
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25690196 ↗InjuryJun 24, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - IMPLANT CAME OUT WHEN I TRIED TO REMOVE THE HEALING ABUTMENT
Patient problems: Failure of Implant
MAUDE report 25614005 ↗InjuryJun 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25456133 ↗InjuryJun 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25456107 ↗InjuryJun 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH OSTEOLYSIS.
Patient problems: Failure of Implant
MAUDE report 25455974 ↗InjuryJun 4, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25394305 ↗InjuryMay 18, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO INFECTION, MOBILITY, AND PERIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 25203000 ↗InjuryApr 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24974306 ↗InjuryApr 21, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24948408 ↗InjuryApr 20, 2026Failure to Osseointegrate
CUSTOMER REPORTED: LIMPLANT LOSS DURING HEALING PHASE - LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 24932937 ↗InjuryApr 15, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24891981 ↗InjuryApr 10, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24845344 ↗InjuryMar 31, 2026Loss of Osseointegration
CUSTOMER REPORTED AN IMPLANT LOSS DUE TO AN OSTEOLYSIS, PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24747539 ↗InjuryMar 31, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24741876 ↗InjuryMar 30, 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 24728077 ↗InjuryMar 18, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24631293 ↗InjuryMar 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO INFECTION AND MOBILITY.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24621640 ↗InjuryMar 14, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24599870 ↗InjuryMar 10, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO PROGRESSIVE BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24558465 ↗
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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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