DS PrimeTaper 68011098 (UDI 07392532276712)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.2 x 9mm OsseoSpeed · Class 2 · Implant
Quick summary
This Dentsply PrimeTaper dental implant has 691 adverse event reports, with no deaths and 689 injuries. Most describe the implant failing to bond with the jawbone, with patients losing the implant; some also report infection or bone loss around it. No recalls name this device. Reports rose sharply, with 382 in the last year compared with 166 in the year before.
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
- 710
- Deaths reported
- 0
- Injuries reported
- 708
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 710 adverse event reports that list this exact device (DI 07392532276712), received between Jun 21, 2023 and Sep 30, 2026 — classified as 708 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (611 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 Osseointegrate611
- Loss of Osseointegration79
- Fracture6
- Adverse Event Without Identified Device or Use Problem5
- Malposition of Device5
- Material Deformation2
- Difficult to Insert1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant690
- Unspecified Infection130
- Osteolysis36
- Inflammation33
- Pocket Erosion15
- Inadequate Osseointegration12
- Implant Pain9
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 25 most recent of 710 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with peri-implantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50943844 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50940202 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50938685 ↗InjurySep 29, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50936953 ↗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 50922019 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50917479 ↗InjurySep 17, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50803552 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50793668 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782563 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50780911 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50773397 ↗InjurySep 15, 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 50770769 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50762598 ↗InjurySep 12, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745560 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50743238 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50688928 ↗InjuryAug 18, 2026Failure to Osseointegrate
It was reported that the patient experienced dental implant loss associated with mobility, osteolysis, and infection.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50304523 ↗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 50297693 ↗InjuryAug 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and Osteolysis.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 50253418 ↗InjuryAug 13, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50233450 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50223725 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50217346 ↗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 50214615 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50207728 ↗InjuryAug 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50196647 ↗
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.