DS PrimeTaper 68011091Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø3.6 x 9mm OsseoSpeed · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply PrimeTaper dental implant has 695 adverse event reports, with no deaths and 694 injuries. Most describe the implant failing to bond with the jawbone, with patients losing the implant; some patients also reported infection, inflammation or bone loss around it. 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
- 712
- Deaths reported
- 0
- Injuries reported
- 712
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 712 adverse event reports that list this exact device (DI 07392532276644), received between Jun 21, 2023 and Sep 30, 2026 — classified as 712 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (620 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 Osseointegrate620
- Loss of Osseointegration75
- Insufficient Device Problem Information8
- Malposition of Device5
- Adverse Event Without Identified Device or Use Problem2
- Difficult to Insert1
- Fracture1
- Material Deformation1
Patient problems
- Failure of Implant696
- Unspecified Infection156
- Inflammation45
- Osteolysis42
- Pocket Erosion22
- Implant Pain9
- Inadequate Osseointegration9
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 712 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50955068 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection
MAUDE report 50955029 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50943935 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50943885 ↗InjurySep 29, 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 50927065 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50926268 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Osteolysis
MAUDE report 50828634 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50810323 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50790769 ↗InjurySep 16, 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 50787396 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50785819 ↗InjurySep 14, 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 50756272 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50690600 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50690519 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656103 ↗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 50418291 ↗InjuryAug 13, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50233440 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss and an unspecified infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50214538 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss and an unspecified infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50214534 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50207825 ↗InjuryAug 6, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. An infection was also reported.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50150747 ↗InjuryAug 5, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50145501 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50091289 ↗InjuryJul 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50081718 ↗InjuryJul 29, 2026Loss of Osseointegration
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 50069190 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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- 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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