DS OmniTaper 68011154Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OmniTaper EV Ø4.5 x 8mm 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 DS OmniTaper dental implant is a root-form endosseous implant. Reports mostly describe failure to osseointegrate and dental implant loss, sometimes with infection. There are 103 reports, no deaths, and 103 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
- 107
- Deaths reported
- 0
- Injuries reported
- 107
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 07392532277030), received between Aug 21, 2023 and Sep 28, 2026 — classified as 107 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (90 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 Osseointegrate90
- Loss of Osseointegration14
- Malposition of Device1
- Osseointegration Problem1
- Separation Failure1
Patient problems
- Failure of Implant103
- Unspecified Infection19
- Osteolysis13
- Inflammation5
- Deformity/ Disfigurement3
- Inadequate Osseointegration3
- Implant Pain2
- Pocket Erosion2
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50915861 ↗InjurySep 17, 2026Osseointegration Problem
Patient problems: Inadequate Osseointegration
MAUDE report 50797023 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50779928 ↗InjuryAug 10, 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 50195834 ↗InjuryAug 8, 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 50185597 ↗InjuryAug 7, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50174297 ↗InjuryAug 5, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50139632 ↗InjuryJul 30, 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 50091288 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50025469 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50025436 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50018804 ↗InjuryJul 13, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25805994 ↗InjuryJun 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25664037 ↗InjuryJun 16, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25524384 ↗InjuryJun 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25522533 ↗InjuryJun 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25354291 ↗InjuryMay 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25271684 ↗InjuryMay 1, 2026Failure to Osseointegrate
CUSTOMER REPORTS AN IMPLANT LOSS - TRANSGINGIVAL HEALING.
Patient problems: Failure of Implant
MAUDE report 25054244 ↗InjuryApr 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24892591 ↗InjuryApr 11, 2026Separation Failure
THE SCREW ON THE TEMPBASE ABUTMENT COULD NOT BE REMOVED. ANOTHER IMPLANT WAS PLACED ¿ THIS WAS CLARIFIED WITH THE PRACTICE OVER THE PHONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24850723 ↗InjuryApr 3, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24781213 ↗InjuryApr 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO INFECTION, PERIIMPLANTITIS, AND PROGRESSIVE BONE LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24769629 ↗InjuryMar 23, 2026Failure to Osseointegrate
CUSTOMER REPORTED TWO IMPLANT LOSSES. DOE: (B)(6) 2026.
Patient problems: Failure of Implant
MAUDE report 24663791 ↗InjuryMar 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24616167 ↗InjuryMar 16, 2026Failure to Osseointegrate
CUSTOMER REPORTED AN NO PRIMARY STABILITY. DIFFERENT IMPLANT SENT THAN NOTED ON CF.
Patient problems: Failure of Implant
MAUDE report 24613853 ↗
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- 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 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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