DS PrimeTaper 68011097 (UDI 07392532258671)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.2 x 8mm 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 endosseous dental implant is a root-form implant used to replace missing teeth. The 70 reports mostly describe implants that fail to bond with the surrounding bone and are later lost, often alongside infection, inflammation, bone breakdown, or gum pocket erosion. All 70 reports involve injuries, with no deaths. No recalls name this device. Reports dropped from 32 in the earlier 12 months to 4 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
- 70
- Deaths reported
- 0
- Injuries reported
- 70
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 07392532258671), received between Oct 13, 2023 and Dec 16, 2025 — classified as 70 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (59 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 Osseointegrate59
- Loss of Osseointegration12
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant70
- Unspecified Infection18
- Inflammation8
- Osteolysis6
- Pocket Erosion5
- Implant Pain2
- Abscess1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 23824938 ↗InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIC INFECTION AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 23603194 ↗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 23577268 ↗InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23552523 ↗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 23433587 ↗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 23433584 ↗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 23433582 ↗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 23433574 ↗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 23433557 ↗InjuryAug 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED INFLAMMATION AND A DENTAL IMPLANT MOBILITY ISSUE AND IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 22920006 ↗InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22888593 ↗InjuryAug 23, 2025Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Implant Pain; Osteolysis; Unspecified Infection
MAUDE report 22880500 ↗InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Pocket Erosion
MAUDE report 22801102 ↗InjuryAug 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22790279 ↗InjuryAug 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22771899 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22711134 ↗InjuryJul 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 22508257 ↗InjuryJul 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22507390 ↗InjuryJul 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 22473539 ↗InjuryJul 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22381140 ↗InjuryMar 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21720842 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21709588 ↗InjuryMar 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21605537 ↗InjuryMar 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21505323 ↗InjuryMar 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21504347 ↗
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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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