DS PrimeTaper 68011105 (UDI 07392532276781)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.8 x 9mm 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. Most of its 329 reports describe implants that failed to bond with the bone or were lost, and some describe infection, bone loss around the implant, and tissue erosion. The reports include no deaths and 329 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
- 342
- Deaths reported
- 0
- Injuries reported
- 342
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 07392532276781), received between Jun 18, 2023 and Sep 30, 2026 — classified as 342 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (275 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 Osseointegrate275
- Loss of Osseointegration52
- Fracture5
- Material Deformation5
- Difficult to Insert2
- Malposition of Device2
- Separation Failure2
- Improper or Incorrect Procedure or Method1
Patient problems
- Failure of Implant328
- Unspecified Infection79
- Inflammation33
- Osteolysis33
- Pocket Erosion14
- Inadequate Osseointegration11
- Implant Pain4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 342 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection and periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50943995 ↗InjurySep 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant failure.
Patient problems: Inadequate Osseointegration
MAUDE report 50937014 ↗InjurySep 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50917648 ↗InjurySep 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50817207 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50816728 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50793452 ↗InjurySep 16, 2026Osseointegration Problem
It was reported that a patient experienced a dental implant loss due to bone loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50790700 ↗InjurySep 16, 2026Loss of Osseointegration
It was reported that a patient experienced dental implant loss accompanied by an infection. No injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789983 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50782216 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50782171 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50782147 ↗InjurySep 14, 2026Fracture
It was reported that a patient experienced a dental implant breakage. The dental implant was explanted as a result.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757011 ↗InjurySep 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to infection.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50754164 ↗InjuryAug 18, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss associated with peri-implantitis.
Patient problems: Osteolysis
MAUDE report 50300130 ↗InjuryAug 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50252701 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50211456 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50207076 ↗InjuryAug 10, 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 50195305 ↗InjuryAug 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50195293 ↗InjuryAug 10, 2026Failure to Osseointegrate
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50194116 ↗InjuryAug 7, 2026Separation Failure
It was reported that a patient experienced a dental implant loss after the healing abutment could not be removed.
Patient problems: Failure of Implant
MAUDE report 50177874 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50111820 ↗InjuryJul 31, 2026Failure to Osseointegrate
It was reported that a patient experienced dental implant loss associated with progressive bone loss due to peri-implantitis at site 23.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 50099599 ↗InjuryJul 30, 2026Separation Failure
It was reported that a bone reamer became stuck, resulting in the removal of the dental implant."
Patient problems: Failure of Implant
MAUDE report 50090011 ↗InjuryJul 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50085297 ↗
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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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