DS OmniTaper 68011149Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OmniTaper EV Ø3.8 x 9.5mm OsseoSpeed · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply OmniTaper dental implant has 270 reports, with no deaths and 268 injuries. Most describe the implant failing to bond with the jawbone or losing that bond, and some describe infection or bone loss around the implant. Reports rose over the last 12 months, to 136 from 84 the year before. 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
- 282
- Deaths reported
- 0
- Injuries reported
- 280
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 07392532276989), received between Jun 29, 2023 and Sep 30, 2026 — classified as 280 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (239 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 Osseointegrate239
- Loss of Osseointegration34
- Fracture6
- Malposition of Device2
- Insufficient Device Problem Information1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant270
- Unspecified Infection54
- Osteolysis28
- Inflammation12
- Inadequate Osseointegration7
- Pocket Erosion5
- No Clinical Signs, Symptoms or Conditions4
- Implant Pain2
Recent adverse event reports
The 25 most recent of 282 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50952748 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50952674 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50938798 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50926507 ↗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 50914681 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50812955 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50765204 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50762978 ↗InjurySep 10, 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 50712804 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss; Mobility.
Patient problems: Failure of Implant
MAUDE report 50477445 ↗InjuryAug 20, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection, osteolysis & progressive bone loss.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50355506 ↗InjuryAug 20, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss during the removal of the cover screw the implant. The patient was not using the temporary complete denture.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50353188 ↗InjuryAug 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50266099 ↗InjuryAug 13, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50243739 ↗InjuryAug 13, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50243673 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50224079 ↗InjuryAug 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50192330 ↗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.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50157557 ↗InjuryAug 5, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50140483 ↗InjuryAug 4, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50127114 ↗InjuryAug 4, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. And also reported was Osteolysis and inflammation.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 50127071 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50046959 ↗InjuryJul 27, 2026Insufficient Device Problem Information
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 50025103 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50024880 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50008065 ↗
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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