DS PrimeTaper 68011099 (UDI 07392532258695)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.2 x 11mm OsseoSpeed · Class 2 · Implant
All models of DS PrimeTaper (61)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply PrimeTaper implant is a screw-shaped device placed into bone. All 182 reports are injuries, with no deaths, and reports in the last 12 months (11) are down from 97 in the prior 12 months. Most describe the implant failing to bond with the bone or being lost, and some mention infection or bone loss. 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
- 182
- Deaths reported
- 0
- Injuries reported
- 182
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 07392532258695), received between Jun 26, 2023 and Aug 3, 2026 — classified as 182 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (146 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate146
- Loss of Osseointegration33
- Insufficient Device Problem Information2
- Malposition of Device1
- Material Deformation1
Patient problems
- Failure of Implant182
- Unspecified Infection33
- Inflammation16
- Pocket Erosion15
- Osteolysis12
- Implant Pain3
- Insufficient Information2
- Numbness1
Recent adverse event reports
The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 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
MAUDE report 50123551 ↗InjuryJun 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25363476 ↗InjuryApr 21, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24948217 ↗InjuryMar 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED IMPLANT MOBILITY ISSUES AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24683946 ↗InjuryMar 5, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24524977 ↗InjuryJan 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED OSTEOLYSIS AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24064481 ↗InjuryDec 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED INFECTION, PAIN, BONE LOSS AND INSUFFICIENT IRRIGATION ASSOCIATED WITH THE DENTAL IMPLANT.
Patient problems: Failure of Implant; Implant Pain; Osteolysis; Unspecified Infection
MAUDE report 23875355 ↗InjuryNov 19, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23600827 ↗InjuryNov 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23576753 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23552543 ↗InjuryNov 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23513785 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23433612 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23433611 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23433607 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23433606 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23433601 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23433599 ↗InjuryOct 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED IMPLANT LOOSENING AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23331605 ↗InjuryAug 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22920108 ↗InjuryAug 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22880531 ↗InjuryAug 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED MOBILITY ISSUES AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22869889 ↗InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED BONE LOSS AT THE NECK OF THE IMPLANT AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 22813286 ↗InjuryAug 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22779883 ↗InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22746729 ↗InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22746279 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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