DS PrimeTaper 68011106 (UDI 07392532276798)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.8 x 11mm OsseoSpeed · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply PrimeTaper implant has 229 adverse event reports, all of them injuries, and no deaths. The reports mostly describe patients losing the implant, often with infection, bone loss or pain, and some describe no initial stability during surgery. No recalls name this device. Reports rose from 52 in the previous 12 months to 96 in the most recent 12 months.
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
- 235
- Deaths reported
- 0
- Injuries reported
- 235
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 235 adverse event reports that list this exact device (DI 07392532276798), received between Jun 20, 2023 and Sep 30, 2026 — classified as 235 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (172 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 Osseointegrate172
- Loss of Osseointegration43
- Fracture9
- Difficult to Insert5
- Malposition of Device3
- Insufficient Device Problem Information2
- Damaged Thread1
- Material Deformation1
Patient problems
- Failure of Implant226
- Unspecified Infection51
- Inflammation23
- Osteolysis20
- Implant Pain13
- Pocket Erosion11
- Inadequate Osseointegration4
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 25 most recent of 235 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.
Patient problems: Osteolysis
MAUDE report 50943330 ↗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 50933480 ↗InjurySep 28, 2026Damaged Thread
It was reported that a patient experienced a dental implant loss after the insertion tool tip broke off inside the implant.
Patient problems: Inadequate Osseointegration
MAUDE report 50917815 ↗InjurySep 17, 2026Fracture
It was reported that a patient experienced a dental implant breakage.
Patient problems: Unspecified Infection
MAUDE report 50805934 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50775069 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50755549 ↗InjurySep 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50734370 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50651251 ↗InjuryAug 26, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and Osteolysis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458276 ↗InjuryAug 25, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with Periimplantitis.
Patient problems: Failure of Implant
MAUDE report 50437782 ↗InjuryAug 13, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50244328 ↗InjuryAug 13, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50244293 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50219882 ↗InjuryAug 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with pain, mobility, and pus.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 50188823 ↗InjuryAug 4, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50128786 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50006296 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. PATIENT ALSO REPORTED AN INFECTION AND PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 25816439 ↗InjuryJul 13, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25806517 ↗InjuryJul 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. NOT INTEGRATED
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25800138 ↗InjuryJul 13, 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 25794397 ↗InjuryJul 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25766127 ↗InjuryJul 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25765974 ↗InjuryJul 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25716016 ↗InjuryJul 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25694105 ↗InjuryJul 1, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25685276 ↗
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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 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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