DS PrimeTaper 68011092Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø3.6 x 11mm OsseoSpeed · Class 2 · Implant
All models of DS PrimeTaper (61)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply PrimeTaper dental implant is placed in the jawbone to hold a replacement tooth. Reports mostly describe implants lost after failing to fuse with the bone, and some mention infection, bone loss or inflammation. There are 895 reports, no deaths and 892 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
- 917
- Deaths reported
- 0
- Injuries reported
- 913
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 917 adverse event reports that list this exact device (DI 07392532276651), received between Jun 18, 2023 and Sep 30, 2026 — classified as 913 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (779 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 Osseointegrate779
- Loss of Osseointegration120
- Adverse Event Without Identified Device or Use Problem5
- Malposition of Device5
- Fracture3
- Insufficient Device Problem Information3
- Difficult to Insert2
- Damaged Thread1
Patient problems
- Failure of Implant891
- Unspecified Infection205
- Osteolysis95
- Inflammation66
- Pocket Erosion40
- Implant Pain14
- No Clinical Signs, Symptoms or Conditions13
- Inadequate Osseointegration12
Recent adverse event reports
The 25 most recent of 917 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50954825 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50944119 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50936753 ↗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 50933085 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with progressive bone loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50917383 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912828 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50829669 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Osteolysis
MAUDE report 50829588 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50829097 ↗MalfunctionSep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient experienced a dental implant fit issue (Surgical Issue).
Patient problems: Insufficient Information
MAUDE report 50812906 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50790908 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50780046 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50779978 ↗InjurySep 12, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745766 ↗InjurySep 12, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745759 ↗InjurySep 12, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745758 ↗InjurySep 12, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745753 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50741764 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50740792 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694832 ↗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 50675742 ↗InjuryAug 25, 2026Failure to Osseointegrate
Patient problems: Failure of Implant
MAUDE report 50438978 ↗InjuryAug 24, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412864 ↗InjuryAug 24, 2026Failure to Osseointegrate
It was reported that a patient experienced dental implant loss due to infection and mobility.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50405130 ↗InjuryAug 21, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with periimplantitis and osteolysis.
Patient problems: Failure of Implant; Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50376343 ↗
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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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